Download 1 Name Of The Candidate And Address (In Block Letters) Dr. K

Rajiv Gandhi University of Health Sciences, Karnataka
Bangalore
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
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Name Of The Candidate
And Address
(In Block Letters)
Name of the Institution
Course of study and
Subject
Date of admission
of Course
Dr. KRISHNAPRASAD.K.R
POST GRADUATE STUDENT.
DEPARTMENT OF PERIODONTICS.
COORG INSTITUTE OF DENTAL SCIENCES,
VIRAJPET.
COORG INSTITUTE OF DENTAL SCIENCES.
MASTER OF DENTAL SURGERY,
PERIODONTICS AND IMPLANTOLOGY
24TH MAY 2007
Title of the Topic
Efficacy of Enamel Matrix Derivative (Emdogain) in root coverage procedure,
as an adjunct to coronally repositioned flap. - A clinical study.
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Brief Resume of the intended work
6.1 Need for the study:
Gingival recession is the apical shift of marginal gingiva, beyond the cemento
– enamel junction. Gingival recession, leads to impaired aesthetics and hyper
sensitivity of the teeth. Root coverage procedures are of prime importance, from
an aesthetic and a functional point of view. Several surgical and non surgical
procedures have been tried to treat the gingival recession, but the predictability of
these procedures are always a matter of concern.
Enamel Matrix Derivative (EMD) is a xeno graft derived from developing
enamel organ of porcine origin and is available as a gel, which is easy to use.
Many studies have shown that, the EMD is a very effective regenerative
material1,3,5, and can be used as an adjunct to the routine regenerative
procedures2,4,6. A thorough review of literature revealed that, the data regarding the
effect of EMD on soft tissue regeneration is sparse, and hence there is a need to
study the efficacy of Enamel Matrix Derivative, as an adjunct to root coverage
procedures.
6.2
Review of literature:
In a study, 12 teeth affected by periodontitis and were scheduled for extraction,
were treated with Emdogain. After 2 to 6 weeks, these teeth were extracted and
were studied by light and electron microscopy. It was concluded that, following
treatment with Emdogain, a bone like tissue resembling cellular intrinsic fibre
cementum may develop on the root surfaces and Emdogain may induce de novo
formation of mineralized tissue on the tooth surfaces1.
In a case report, six cases with localized gingival recession on maxillary
canines were treated with coronally repositioned flap, along with the application of
Emdogain gel. These cases were followed for 12 months. This article describes the
clinical procedure and out come of the surgical treatment of gingival recessions
with Emdogain as an adjunct. It can be concluded from the results of this article,
that the use of enamel matrix proteins along with coronally repositioned flap gives
a predictable treatment procedure for root coverage2.
A study was conducted to evaluate the effect of Emdogain on cultured gingival
fibroblasts. The cells were cultured in media containing different concentrations of
Emdogain. This study concludes that the Emdogain exerts a positive influence on
wound healing and it is best at a concentration of 20μg/ ml5.
A study evaluated the effect of Emdogain on healing of soft tissue wound
produced by periodontal pocket instrumentation. Teeth with probing pocket depth
more than 5mm were considered for the study. Scaling and root planing was done
for these teeth followed by application of enamel matrix protein on the
experimental sites. These were followed up for 3 weeks and it was concluded that
the wound healing may be improved with the use of Emdogain6.
6.3 Objectives of the study:
1. To assess the efficacy of Enamel Matrix Derivative as an adjunct to
coronally repositioned flap in treating gingival recession.
2. To evaluate the extent of soft tissue root coverage using Enamel Matrix
Derivative with coronally repositioned flap and its stability.
3. To compare healing of the surgical wound with and with out the use of
Enamel Matrix Derivative.
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Materials And Methods:
7.1 Source of data
Out patients in the Department of Periodontics and Implantology, Coorg Institute
of Dental Sciences, Virajpet.
7.2 Method of collection of data:
Inclusion Criteria.
 Healthy individuals with out any systemic diseases.
 Patients who can follow the instructions and maintain a good oral hygiene.
 Presence of two or more sites with Millers class I recession, of at least 4mm
in depth, in the anterior sextants.
 Presence of keratinized tissue apical to the lesion.
 No class V restoration on the teeth.
Exclusion Criteria
 Traumatic occlusion.
 Patients with systemic disease.
 Pregnant women.
 Patients on systemic medications.
 Patients under going orthodontic treatment.
 Areas with severe mal alignment of teeth.
 Patient who have under gone periodontal surgery.
 Patients with a habit of tobacco use.
Methodology:
This will be a split mouth clinical study, with a sample size of 10 patients
(i.e. at least 20 sites). The subjects will be enrolled in to the study after informing
them regarding the study and a written consent is taken from them. All the subjects
will be given a thorough oral prophylaxis and oral hygiene instructions. Base line
evaluation will be done one week after the phase I therapy. The surgical sites will
be randomly divided in to experimental site and control site before the surgery.
Coronally repositioned flap procedure will be performed as described by
Wennstrom and Pini Prato, during which the Enamel Matrix Derivative will be
applied on the experimental sites after the flap is raised. The subjects will be
followed up at periodic intervals i.e. after 1 week, 3 weeks, 6 weeks, 12 weeks and
24 weeks of the surgery. The recession depth, probing pocket depth and the
clinical attachment level will be measured using UNC 15 probe and recorded to the
nearest millimeter. The recording of the data will be standardized using
customized acrylic stents. All the data will be tabulated and analyzed using paired
students T test and unpaired students T test.
Clinical Parameters.
 Recession depth.
 Probing depth.
 Clinical attachment level.
7.3 Does the study require any investigations or interventions to be
conducted on the patients or other humans or animals? ( If so please
describe briefly )
Yes. Coronally repositioned flap procedure will be performed on the
subjects as described by Wennstrom and Pini Prato. Enamel Matrix
Derivative will be applied on to the experimental sites after the flap is
raised. All the subjects will be followed up for a period of 6 months after the
surgery.
7.4 Has Ethical clearance been obtained from your institution in case of 7.3?
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Yes
List of references:
1. Bosshardt DD, Sculean A, et al. Effects of Enamel Matrix Proteins on tissue
formation along the roots of human teeth. J Periodont Res.2005; 40; 158-167
pp.
2. Frank. Abbas, Jan Wennstrom, et al. Surgical treatment of gingival recessions
using Emdogain gel: clinical procedure and case reports. Int. J Periodontics
Restorative Dent. 2003; 23:607-613 pp.
3. Hammarstrom L. Enamel matrix, cementum development and regeneration. J
Clin Periodontol 1997; 24: 658 -668 pp.
4. Ignazio Berlucchi, Luca Francetti, et al. Enamel Matrix Proteins (Emdogain) in
combination with coronally advanced flap or sub epithelial connective tissue
graft in the treatment of shallow gingival recessions. Int J Periodontics
Restorative Dent, 2002; 22: 583-593 pp.
5. Rincon JC, Hasse HR and Bartold PM. Effect of Emdogain on human
periodontal fibroblasts in an in vitro wound healing model. J Periodont Res.
2003; 38; 290-295pp.
6. Wennstrom JL, Lindhe J. Some effects of enamel matrix proteins on wound
healing in the dento – gingival region. J Clin Periodontol. 2002; 29: 9 -14 pp
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Signature of the candidate:
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Remarks of the guide:
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Name and designation:
Guide:
Prof. Dr. Girish Suragimath.
Professor, Department of Periodontics and Implantology.
Signature:
Co – guide ( if any):
Signature:
Head of the department:
Prof. Dr. Srinivas M.
Professor and H O D, Department of Periodontics and Implantology.
Signature:
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Remarks of the Chairman and Principal:
Signature: