Download Proforma for registration of subjects for dissertation

RAJIV GANDHI UNIVERSITY OF HEALTH
SCIENCES, BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR THE REGISTRATION
OF
SUBJECT FOR DISSERTATION
BY
DR. DIVYA KHANNA
1ST YEAR MDS
DEPARTMENT OF PERIODONTOLOGY
2013
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES AND
HOSPITAL
BANGALORE- 562157
1
RAJIV GANDHI UNIVERSITY
SCIENCES, KARNATAKA
OF
HEALTH
Proforma for registration of subjects for dissertation
1. Name of the candidate and DR. DIVYA KHANNA
Post Graduate Student,
address:
Department Of Periodontology,
Krishnadevaraya College Of Dental Sciences,
Krishnadevarayanagar, Hunasamaranahalli,
Bengaluru – 562157
2. Name Of The Institution:
Krishnadevaraya College Of Dental Science
& Hospital.
3. Course of the study and Master of Dental Surgery
Periodontology.
subject:
4. Date of admission of the 5 June 2013
course
5. Title of the topic
Pinhole Surgical Technique With And Without
Use Of Button Application For Treatment Of
Multiple Gingival Recessions: A Comparative
Controlled Randomized Clinical Trial.
2
6 .BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR STUDY
Gingival recession is a term that designates the oral exposure of root surfaces due to
displacement of the gingival margin apical to cementoenamel junction1, sequelae of which
results in unfavourable esthetics, increased root caries susceptibility2 and dentin
hypersensitivity3, hence periodontal therapy is indicated.
Millers Class I and Class II recession defects mainly occur in multiple buccal areas and the
main etiologic factors include trauma from tooth brushing, malposition of teeth, ectopic
insertion of frenum and muscle attachment. Millers Class III and Class IV recessions usually
involve the whole mouth and is often related to plaque associated chronic inflammatory
periodontal disease.4 These recession defects involving many adjacent teeth were termed as
multiple adjacent recession type defects (MARTD)5 or Multiple Recession Type Defects
(MRTD).6 These terminologies have been used interchangeably in scientific literature.
Complete root coverage of multiple recession type defects (MRTD) and an optimal
integration of the associated tissues is an essential component of perioplastic surgery which is
a demanding, continuously evolving and promising field.
A variety of perioplastic procedures have been described to achieve soft tissue coverage of
the exposed root surfaces in multiple adjacent recession type defect e.g.coronally advanced
flap7(CAF), coronally advanced flap with Subepithelial Connective Tissue Graft8(SCTG),
expanded mesh connective tissue graft with coronally advanced flap4, coronally advanced
flap combined with orthodontic button application5, tunnel technique with subepithelial
connective tissue graft9 and modifications10, vestibular incision subperiosteal tunnel access
techique11, free gingival autograft12, periosteal pedicle graft13, rotated papilla autograft14 ,
semilunar repositioned flaps15 and Guided Tissue Regeneration (GTR).16,17
Treatment protocol and outcome of multiple adjacent recession type defects with different
surgical procedures depends on many factors like recession defect size, presence or absence
of keratinized tissue adjacent to the defect, width and height of interdental soft tissue, depth
of vestibule, presence of frenum18, post operative stabilization and final position of advanced
gingival margin.17
When MRTD are present, an approach to address all recession defects at one single surgical
visit is the preferred choice3, coronally advanced flap alone and with various modifications
have been used widely and successfully. But these techniques have certain limitations such as
technique sensitivity, invasive, long procedural time is required, high morbidity and
associated complications due to a second surgical site like post-operative pain, bleeding,
swelling and long healing periods and this has led to the need for a newer minimally invasive,
practical, short duration, single site surgery and patient centred approach in the management
of MRTD.
Pin hole surgical technique19 is one such novel technique which holds promise as a minimally
invasive, predictable, efficient, time and cost-effective procedure for recession coverage in
3
MRTD. This procedure is based on only a single incision 2–3 mm for access in the alveolar
mucosa at the base of recipient recession site , with no releasing incision, suturing and sharp
dissections. The entire procedure can treat 3-10 recession defects with a single incision.19
Such newer techniques are here to stay and advance in perioplastic surgical procedures.
However there are very few controlled clinical trials reporting this procedure and its
comparison with other techniques of recession coverage in MRTD. The most important part
of any perioplastic surgery for recession coverage is the anchorage and stabilization of the
displaced flap during first two weeks of wound healing.5 Coronally advanced flap with button
application for stabilization of sutures and coronal stabilization of advanced flap showed
better results than coronally advanced flap alone in treatment of MRTD.5 Its been shown that
the greater post operative displacement of gingival margin may cause greater root
coverage.20,27 Hence the modification of pinhole surgical technique with orthodontic button
application and suturing may show enhanced root coverage as compared to pinhole surgery
alone. There is a need for more research to be carried out to analyze the success of pinhole
surgical technique in management of multiple recession defects.
Thus the aim of this randomized controlled trial is to compare and evaluate the efficiency of
pinhole surgical technique with and without application of buttons and sutures in the
management of MRTD.
6.2 REVIEW OF LITERATURE:
Zucchelli and Sanctis (2000) conducted a case series study to evaluate root coverage with a
new surgical approach to the coronally advanced flap procedure for treatment of multiple
recession defects in patients with esthetic demands at 1 year examination. The results showed
88% complete root coverage and greater reductions in recession in cases with less amount of
keratinized tissue apical to recession defect.18
Zucchelli et al. (2005) conducted a long term case series (5 years) for treatment of Multiple
Adjacent Recession Defects (MRTD) using envelope type coronally advanced flap and the 5
year follow up showed, increased in keratinized tissue and 85% of treated recessions defects
showed complete root coverage.25
Chambrone et al. (2009) conducted a systematic review of periodontal plastic surgery in the
treatment of multiple recession type defects and concluded that the mean width of keratinized
tissue increased significantly and mean root coverage achieved ranged from 94% - 98% and
the need for more randomized controlled trials to identify the indication for each surgical
technique.6
Pini Prato et al. (2010) conducted a split mouth randomized controlled study to evaluate
coronally advanced flap versus connective tissue graft in the treatment of multiple gingival
recessions with a 5 year follow up and concluded that 52% sites showed completed root
4
coverage when treated with coronally advanced flap and connective tissue graft in
comparison to 35% coverage in coronally advanced flap treated sites.8
Zadeh (2011) conducted a case series to introduce a new minimally invasive treatment of
multiple gingival recession defects in maxillary anterior region by vestibular incision
subperiosteal tunnel access technique. The result showed good outcome in esthetic zones.11
Ozcelik et al. (2011) conducted a randomized controlled trial for treatment of multiple
recession defects using coronally advanced flap combined with orthodontic button
application and the result showed 84% complete root coverage and high patient satisfaction
with esthetic demands.5
John Chao (2012) introduced a novel approach for treatment of multiple recession defects
using a Pin Hole Surgical Technique and concluded that 94% mean defect reduction was
obtained along with minimum post operative complications and optimal patient based
outcome.19
6.3 OBJECTIVE OF STUDY
The Primary objective of this study is to compare and evaluate the effectiveness and
predictability of Pinhole surgical technique alone and its modification with orthodontic
buttons and sutures in the treatment of multiple adjacent recession defects.
The following primary outcomes will be assessed - the difference in Gingival recession width
(GRW), Gingival recession depth (GRD), Complete root coverage (CRC) and root coverage
esthetic score (RES).
The secondary objectives of the study will be to assess the influence of these surgical
procedures on the gingival and periodontal health. The secondary outcomes that will be
assessed are difference in probing pocket depth (PD), relative attachment level (RAL) and
width of keratinized tissue (KTW).
7. MATERIALS & METHODS
7.1 SOURCE OF DATA
Patients referred to Department of Periodontology, Krishnadevraya College of Dental
Sciences and Hospital and satisfying the inclusion and exclusion criteria will be selected for
the study.
5
7.2 METHOD OF COLLECTION OF DATA
Sample Size:
The prospective study will be a single blind comparative controlled randomized clinical trial
with 40-50 recession defects in each study group. Patients with atleast two or three18 teeth
having Millers Class I, II or combination of class I and II recession defects19 in the maxillary
arch will be selected.
Inclusion Criteria:

Multiple (atleast two or three) Millers class I and II or combined class I and II
recession defects19 affecting adjacent teeth of the maxillary arch.

Patients with thick gingival biotypes >0.8mm.24

Presence of adequate keratinized tissue apical to recession > 1mm.5

Age group 25-55 years.20

Patients with history of compliance to oral hygiene instructions and a full mouth
plaque score of <10%. (O Leary 1972)

Patients willing to participate in the study.

American Society of Anaesthesiologists Physical Status I or II.19, 21

No contra-indications for periodontal surgery.19

Non-Smokers.22,23

Patients with esthetic concerns.25
Exclusion Criteria:






Recession defects associated with caries/demineralization, restorations, and deep
abrasions (step >2mm).5
No occlusal interferences.5
Teeth with evidence of pulpal pathology.5
Patients who have undergone any previous periodontal surgical procedures at the
involved sites.19
Pregnant and lactating women.
Patients on medications known to interfere with periodontal tissue health or healing.29
6
SAMPLING TECHNIQUE
1. The patients will be assigned into two treatment groups (test and control). The test
group will be treated with pinhole surgical technique using buttons and sutures for
flap advancement and stabilization, the control group will be treated by pinhole
surgery alone.
2. After screening examination in the initial phase, each subject will receive a session of
oral hygiene instructions, scaling and root planing with ultrasonic scalers and manual
curettes.
3. A coronally directed roll technique for brushing will be prescribed for teeth with
recession defects to minimize the tooth brushing trauma to the gingival margin.29
4. Surgical treatment of the recession defects will not be scheduled until the patient can
demonstrate an adequate standard of supragingival plaque control (plaque score <10%
O Leary 1972). The below mentioned clinical parameters will be recorded to the
nearest millimeter using a UNC-15-probe5 (University of North Carolina -15
periodontal probe – Hu Friedy, Chicago, IL, USA.) and measuring occlusal stents for
positioning measuring probes will be fabricated with cold-cured acrylic resin on a cast
model obtained from an alginate impression. It will be produced so that it covers the
occlusal surfaces of the tooth being treated and the occlusal surfaces of atleast one
tooth in the mesial and distal directions. It will also be extended apically on the buccal
and lingual surfaces to cover the coronal third of the teeth. Three grooves will be
marked on the stent at mesio-buccal, mid-buccal and disto-buccal sites as
standardized reference points26 so that post surgical measurements will be made at the
same position and angulation as those made before surgery. Measurements will be
recorded before surgery ie. baseline measurements then after 6 weeks, 3 months and 6
months. All measurements will be carried out by a single masked examiner. Prior to
the study, the examiner will be calibrated to reduce intra examiner error (kappa >0.75)
and to establish reliability and consistency.29
Clinical Measurements
The following clinical measurements will be recorded at baseline, 6weeks, 3months and
6months.
1. Gingival Recession Depth (GRD), measured as the distance between the most apical
margin of occlusal stent and the gingival margin.5
2. Gingival Recession Width (GRW), measured as the distance between the mesial
gingival margin and distal gingival margin (measurement will be recorded on a
horizontal line tangential to the cementoenamel junction).5
3. Probing Depth (PD), measured as the distance from the gingival margin to the base of
gingival sulcus.19
4. Relative Attachment Level (RAL), measured as the distance from the apical border of
the occlusal stent to the base of the gingival sulcus.19
7
5. Apico-coronal width of keratinized tissue (KTW) measured as the distance from the
mucogingival junction to the gingival margin ,with the mucogingival junction
location determined using a visual method (Schiller’s Potassium Iodide Solution).5
6. Location of Gingival margin after suturing with respect to occlusal stent is calculated
by subtracting the distance between stent margin and gingival margin from the
distance between stent margin and gingival margin after suturing.27
7. Plaque Index -Silness and Loe 1964.
8. Gingival Bleeding Index –Ainamo and Bay 1975.
9. Gingival Index – Loe and Silness 1963.
1.
2.
3.
4.
The following parameters will be included with the above mentioned measurements
during recall at 6 weeks, 3 months and 6 months.
Recession depth reduction.5
Mean root coverage.5
Complete Root Coverage.5
Esthetic evaluations according to Root Coverage Esthetic Score System.28
SURGICAL PROCEDURE:









Before starting the surgery, root surfaces near to buccal attachment loss will be
instrumented with mini-five Gracey curettes and the mechanical treatment will be
terminated when smooth and hard root surfaces will be obtained.5,29
Under injection of local anaesthesia 2% lignocaine hydrochloride (Lignox 2%, Indoco
Remedies Ltd, Goa, India.) using a No. 15 scalpel (Bard Parker), a minimum
horizontal incision of 2-3 mm will be made in the alveolar mucosa near the base of
vestibule, apical to recipient sites.19
Papilla elevator (TKN2, Hu Friedy, Chicago, IL, USA.) will be inserted through the
entry incision and a full thickness mucoperiosteal flap will be elevated.19
Elevation of flap will be guided by visualization of the shape and movement of
instrument through mucosa and gingival tissue.19
Flap reflection will then be extended coronally and horizontally to allow for elevation
of two adjacent papillae on each side of denuded roots.
The interproximal extension of flap will result in a freely movable flap, which will be
then positioned coronally to extend beyond cementoenamel junction (CEJ).
For flap stabilization, a malleable bioresorbable collagen membrane11 (HealiguideTM,
EnColl Corp. USA) will be used (2x12mm strips pre-soaked in sterile water) and
tucked with curved tissue forceps into sub-gingival spaces under the papillae and
marginal soft tissue (actual number of strips used will depend on the amount of
material needed to secure the flap in desired position).19
Tissue tension created by distension or pouching of the flap will hold the graft strips
in place (without sutures or tissue adhesives).
Gentle digital pressure will be applied for 5 minutes approximately.15,19
8







The incision will be left to heal by primary intention without suturing.
However in the Test group, before starting the surgery, orthodontic buttons (Prime
orthodontics, Inc. Portland, USA) will be applied on the middle of middle one third of
the crown of tooth with dental cement (dual cure glass ionomer cement 3M ESPE,
USA) and cured with light until hardened.5
Surgical procedure of flap reflection will be identical to control group and flap will be
maintained in a coronally position by suspended sutures around the orthodontic
buttons on teeth and around teeth. The sling sutures with 5-0 ( non absorbable surgical
sutures, Mersilk, Ethicon, Johnson & Johnson, Himachal Pradesh, India.) will be used
to suspend the central area of the flaps on the buttons. These sling sutures will allow
for the most coronal positioning of the flaps. The second sutures with 6-0 (non
absorbable surgical sutures, Mersilk, Ethicon, Johnson & Johnson, Himachal Pradesh,
India.) will be performed to accomplish a precise adaptation of the buccal flap on the
convexity of the underlying crown surface and permitted the stabilization of every
surgical papilla.5 At the end of surgery, the flap margins will be at least 3-4mm
coronal to CEJ of all teeth. Periodontal dressing (Coe Pack – non eugenol periodontal
dressing, GC America Inc. ALSIP, IL, USA.) will be applied to avoid any mechanical
trauma.5
Post-operative instructions will consist of 0.12% chlorhexidine gluconate mouth rinse
3 times daily for 1 minute and avoidance of brushing at surgical site for 6 weeks19 will
be advised to the patient.
Post operative pain and edema will be controlled with non steroidal anti inflammatory
drug (Tab Ibuprofen 400mg thrice daily for three days) and antibiotic (Cap
Amoxicillin 500 mg thrice daily for seven days), if patient is allergic to pencillins
(Cap Clindamycin 300 mg four times daily for seven days) after meals will be
prescribed. Patients will be advised to consume only soft and warm food during the
first week.5
The sutures, orthodontic buttons and periodontal dressing will be removed 14 days
after surgery. After this period, patients will be reinstructed in mechanical cleaning of
the treated teeth and use of a soft toothbrush and roll technique of brushing for 1
month.29
Patient will be recalled for reinforcement of oral hygiene instructions and light
debridement with ultrasonic scalers supragingivally will be carried out. Clinical
parameters will be recorded at 6 weeks, 3 months, 6 months after surgical
reconstruction.
Statistical Analysis
For each continuous variable, normality will be checked by Kolmogorov – Smirnov and
Shapiro – Wilk tests and by histograms. Comparison between independent groups will be
done by using the student t - test or Mann – Whitney U test. Data between the time
dependent groups will be analysed by paired t - test or Wilcoxons rank sum test. The
categorical variables between the groups will be analysed by using the x2 – test.
9
7.3 Does the study require any investigation or intervention to be done on humans or
animals?
Yes. The study requires a pin hole surgical approach on the control site and an additional
application of orthodontic buttons and sutures on the test site in humans.
7.4 Has the ethical clearance been obtained from your institution in the case above?
Yes. A copy of the same has been enclosed.
10
LIST OF REFERENCES:
1) Periodontology. AAo. Glossary of Periodontal Terms. ed4: American Academy of
Periodontology 2001.
2) Lawrence HP, Hunt RJ, Beck JP. Three Year root caries incidence and risk modelling
in older adults in North Carolina. J Public Health Dentistry 1995;55: 69-78.
3) Carvalho P, Da.Silva RC, Cury P. Modified coronally advanced flap associated with a
subepithelial connective tissue graft for treatment of adjacent multiple recessions. J
Periodontol 2006;77:1901-06.
4) Cetiner D, Bodur A, Uraz A. Expanded mesh connective tissue graft for the treatment
of multiple gingival recessions. J Peridontol 2004;75:1167-1172
5) Ozcelik O, Haytac MC, Seydaoglu G. Treatment of multiple gingival recession using
a coronally advanced flap procedure combined with button application. J Clin
Periodontol 2011;38:572-80.
6) Chambrone L, Lima LA, Pustiglione FE, Chambrone LA. Systematic review of perioplastic surgery in the treatment of multiple recessions type defects. JCDA
2009;75:203(a) 203(f).
7) Bernimoulin P, Luscher B, Muhlemann HR. Coronally repositioned periodontal
flap:Clinical evaluation after one year. J Periodontol 1975;2:1-13.
8) Pini Prato GP, Cairo F, Nieri M, Franceschi D, Rotundo R, Cortellini P. Coronally
advanced flap versus connective tissue graft in treatment of multiple gingival
recessions: a split mouth study with 5year follow up. J Periodontol 2010;37:644-650.
9) Zabalegui I, Sicilia A, Cambra J, Gil J. Treatment of multiple adjacent gingival
recessions with tunnel subepithelial connective tissue graft: A clinical report. Int J
Periodontics Restorative Dent 1999;19:199-206.
10) Tozum TF, Dini FM. Treatment of adjacent gingival recessions with subepithelial
connective tissue graft and modified tunnel technique. Quintessence International
2003;34:7-13.
11) Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession
defects by vestibular incision subperiosteal tunnel access and platelet derived growth
factor BB. Int J Periodontics Restotative Dent 2011;31:653-660.
12) Livingston HL. Total coverage of multiple and adjacent denuded root surfaces with a
free gingival autograft: A case report. J Periodontol 1975;46:209-216.
13) Mahajan A. Treatment of multiple gingival recession defects using periosteal pedicle
graft: A case series. J Periodontol 2010;81:1426-1431.
14) Tinti C, Benfenati SP. The free rotated papilla autograft: A new bilaminar grafting
procedure for the coverage of multiple shallow gingival recessions. J Periodontol
1996;67:1016-1024.
11
15) Tarnow DP. Semilunar
1986;13:182-185
coronally
repositioned
flap.
J
Clin
Periodontol
16) Rotundo R, Nieri M, Mori M, Clauser C, Prato G. Aesthetic perception after root
coverage procedure. J Clin Periodontol 2008;35:705-712.
17) Pini-Prato G, Clauser C, Magnani C, Cortellini P. Resorbable membrane in the
treatment of human buccal recession: 9 case report. Int J Periodontics Restorative
Dent 2005;15:258-67.
18) Zucchelli G and Sanctis M. Treatment of multiple adjacent recession defects in
patients with esthetic demands. J Periodontol 2000;71:1506-1514.
19) Chao J. A novel approach to root coverage: Pinhole surgical technique. Int J
Periodontics Restorative Dent 2012;32:521-531.
20) PiniPrato G, Baldi C, Pagliaro U, Nieri M, Rotundo R, Cortellini P. Coronally
advanced flap procedure for root coverage. Treatment of root surfaces: Root planning
versus polishing. J Periodontol 1999;70:1064-1076.
21) Maloney WJ, Weinberg MA. Implementation of American society of
anesthesiologists physical status classification system in periodontal practice. J
Periodontol 2008;79:1124-1126.
22) Trombelli L, Scabbia A. Healing response of gingival recession defects following
guided tissue regeneration procedures in smokers and non smokers. J Clin
Periodontol 1997;24:529-533.
23) Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Limo LA. Influence of
tobacco smoking on the outcome achieved by root coverage procedures:A systematic
review. JADA 2009;140:294-306.
24) Baldi C, PiniPrato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, Cortellini P. Coronally
advanced flap procedure for root coverage : A 19 case series. J Periodontol
1999;70:1077-1084.
25) Zucchelli G, De Sanctis M. Long term outcome following treatment of multiple
Miller Class I and II recession defects in esthetic ares of mouth. J Periodontol
2005;76:2286-2292
26) Huang LH, Neiva REF, Wang HL. Factors affecting the outcomes of coronally
advanced flap root coverage procedures. J Periodontol 2005;76:1729-1734 .
27) Pini-Prato G, Baldi C, Nieri M, Franseschi D, Cortellini P, Clauser C, Rotundo R,
Muzzi L. Coronally advanced flap: post surgical position of gingival margin is an
important factor for achieving complete root coverage. J Periodontol 2005;76,713722.
12
28) Cairo F, Rotund R, Miller PD Jr., PiniPrato G. Root coverage esthetic score: a system
to evaluate the esthetic outcome of treatment of gingival recession through evaluation
of clinical cases. J Periodontol 2009;80:705-710
29) Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M.
Coronally advanced flap with and without vertical releasing incisions for the
treatment of multiple gingival recessions: A comparative controlled randomized
clinical trial. J Periodontol 2009;80:1083-1094.
30) Hwang D, Wang HL. Flap thickness as a predictor of root coverage: A systematic
review. J Periodontol 2006;77:1625-1634.
13
09. Signature of the candidate
10. Remarks of the guide
11. Name and designation
11.1 Guide
Dr. JOANN PAULINE GEORGE
PROFESSOR
11.2 Signature
11.3 Co Guide
---11.4 Signature
11.5 Head of the Department
Dr. PRABHUJI MLV
PROFESSOR
11.6 Signature
12.1 Remarks of the Principal
12.2 Signature
14
KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES
HOSPITAL HUNASAMARANAHALLI, BANGALORE-562157
AND
Ethical clearance for dissertation study “ PINHOLE SURGICAL TECHNIQUE WITH
AND WITHOUT USE OF BUTTON APPLICATION FOR TREATMENT OF
MULTIPLE GINGIVAL RECESSIONS : A COMPARATIVE CONTROLLED
RANDOMIZED CLINICAL TRIAL” by Dr. DIVYA KHANNA, postgraduate student in
the Department of Periodontics, Krishnadevaraya College of Dental Sciences and Hospital,
under Rajiv Gandhi University of Health Sciences, Karnataka.
Ethical committee meeting was held on November 5th 2013 in the Boardroom of
Krishnadevaraya College of Dental Sciences & Hospital.
The Members discussed all the ethical issues involved
1. Review of literature and remarks of previous studies.
2. Risks and expected beneficial effects.
3. Cost factor.
4. Supervision by Senior Staff members.
5. ICMR guidelines for Research studies.
The members were satisfied regarding all the above Ethical issues concerned and ethical
clearance was granted for the Dissertation Study.
ETHICAL COMMITTEE MEMBERS
SN NAME AND DESIGNATION
POSITION
1
Dr. H. Nandakumar, Principal & HOD, Dept. of Chairman
SIGNATURE
Oral & Maxillofacial Surgery
2
Dr. Sharath Chandra, Prof & HOD, Dept. of Co- Chairman
Conservative Dentistry
3
Mr. Gundu Rao, NGO, Social Activist
Member
4
Mr. Mohumed Sadiqh B.A, Advocate
Member
5
Dr. Vijay Mohan Reddy.N.H, Administrative Member
Medical Officer, Government General Hospital,
Yelahanka
15
6
7
Dr. Srinivasa. G.N, Physician, Government
General Hospital
Dr. Nikhilananda Hegde, HOD, Orthodontics
Member
8
Dr. Prabhuji MLV, HOD, Periodontics
Member
9
Dr. ShivaShankar, Prof. & HOD, Prosthodontics
Member
10
Dr. M.B.Radhika, Prof.& HOD, Oral Pathology
Member
11
Dr. Murali.R, Professor & HOD, Public health Member
dentistry
12
Dr. Deepak Vishwanath, Professor & HOD, Member
Pedodontics
13
Dr. Vijeev Vasudevan, Professor& HOD, Oral
Medicine
Member
14
Dr. N. Srinath, Professor, Oral Surgery
Member
15
Dr. H.S.Prabhakar, Anesthetist, KHRC
Member
16
CONSENT FORM
I, ……………….. aged…………. yrs, son/daughter/wife /husband of
………………….. here by authorize Dr. DIVYA KHANNA, working at
KCDS & HOSPITAL, to perform any diagnostic examination and surgical
procedure under local anaesthesia.
The nature of the condition and any possible complications of the
procedure have been explained to me in the language I understand by my
surgeon in presence of …………………………………… (witness).
I also agree that if any untoward incident happens, which is beyond the
surgeon’s control, no responsibility will be attached to the
surgeon(s)/hospital/ staff.
I also agree and give my full consent to participate in the study conducted
in Department of Periodontology, KCDS & Hospital, and the nature of the
study having been explained to me by my surgeon (s).
I declare that I am of sound mind and I am giving this consent with my
own decision & willingness and not under any compulsion or pressure by
any of the hospital staff/doctors, after having read and understood the
contents of the consent form.
Name of the procedure: PINHOLE SURGICAL TECHNIQUE WITH
AND WITHOUT USE OF BUTTON APPLICATION FOR TREATMENT
OF MULTIPLE ADJACENT RECESSIONS : A COMPARATIVE
CONTROLLED RANDOMIZED CLINICAL TRIAL.
Signature of the patient/person giving consent
WITNESS SIGNATURE
1.
2.
17
ANNEXURE-Ị
GINGIVAL INDEX (Loe and Silness, 1963)
Method:
The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and
lingual margin of selected teeth.
A blunt instrument is used to assess the bleeding potential of tissues
The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or
pressure to establish the presence or absence of bleeding.
Scoring criteria:
SCORE
CRITERIA
0
Absence of inflammation/normal gingiva.
1
Mild inflammation, slight change in color, slight edema; no bleeding on probing
2
Moderate inflammation; moderate glazing, redness, edema and hypertrophy.
Bleeding on probing.
3
Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to
spontaneous bleeding
G.I SCORE = Total score
No. of teeth examined
Rating
Score
Mild gingivitis
Moderate gingivitis
Severe gingivitis
0.1 - 1.0
1.1 - 2.0
2.1 - 3.0
18
ANNEXURE-II
PLAQUE INDEX (Sillness T and Loe H, 1964)
Method:
The scoring is done on the entire dentition or on selected teeth. Plaque of the cervical third of
the tooth is evaluated with no attention to plaque that has extended to the middle or incisal
thirds. The surfaces examined are the four gingival areas of the tooth i,e the disto-facial,
facial, mesio-facial, and lingual surfaces.
A mouth mirror, a light source, dental explorer, and air drying of the teeth and gingiva are
used.
Scoring criteria:
SCORE
CRITERIA
0
No plaque
1
A film of plaque adhering to the free gingival margin and adjacent area of the
tooth. The plaque may be in situ only after application of disclosing solution or by
using probe on the tooth surface.
2
Moderate accumulation of soft deposit within the gingival pocket, or the tooth and
the gingival margin which can be seen with naked eye.
3
Abundance of soft matter within the gingival pocket and/or on the tooth and
gingival margin.
P.I SCORE= Total score
No. of teeth examined
Rating
Excellent
Good
Fair
Poor
Score
0
0.1 – 0.9
1.0 – 1.9
2.0 – 3.0
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ANNEXURE-III
GINIVAL BLEEDING INDEX (Ainamo J and Bay I, 1975)
The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable
way for assessing a patient’s progress in Plaque control. The presence or absence of gingival
bleeding is determined by gentle probing of the gingival crevice with a periodontal probe.
The appearance of bleeding within 10 seconds indicates a positive score, which is expressed
as percentage of the total number of gingival margin examined.
Scoring criteria:
SCORE
CRITERIA
0
No bleeding present on probing within 10 seconds.
1
Bleeding present on probing within 10 seconds.
Calculation:
Total score
No. of teeth examined
20
ANNEXURE-IV
ROOT COVERAGE ESTHETIC SCORE SYSTEM (Cario et al. 2009)
The Aesthetic evaluation was performed according to the root coverage aesthetic score
system (RES).28
5 Variable evaluated which are as follows:
a.
b.
c.
d.
e.
Gingival margin position (GM)
Marginal Tissue Contour (MTC)
Soft Tissue Texture (STT)
MGJ alignment
Gingival Colour (GC)
Gingival Marginal Position/Level (GM)
SCORE
0
3
6
CRITERIA
Failure of Root Coverage
Partial Root Coverage
Complete Root Coverage
Marginal Tissue Contour (MTC)
SCORE
CRITERIA
0
Irregular gingival margin (doesn’t follow
the CEJ)
1
Proper contour/scalloped gingival margin
(follows the CEJ)
Soft Tissue Texture (STT)
SCORE
0
1
CRITERIA
Scar formation and/or keloid-like
appearance
Absence of scar or keloid formation
21
Mucogingival junction alignment (MGJ)
SCORE
0
1
CRITERIA
MGJ not aligned with the MGJ of
adjacent teeth
MGJ aligned with the MGJ of adjacent
teeth
Gingival Colour (GC)
SCORE
0
1
CRITERIA
Colour of tissue varies from gingival
colour at adjacent teeth
Normal colour integration with the
adjacent soft tissues
Ideal Aesthetic Score = 10
0 Point Assigned If:
a. Final position of the GM was equal or apical to the previous recession depth
(failure of root-coverage procedure) irrespective of colour, the presence of a scar,
MTC or MGJ.
b. Partial or total loss of inter-proximal papilla (black triangle) occurred following
the treatment.
22