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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE
AND ADDRESS
Dr. ERIC MARIO SHAILANDER A.,
POST GRADUATE STUDENT,
DEPARTMENT OF PERIODONTICS,
THE OXFORD DENTAL COLLEGE,
HOSPITAL AND RESEARCH CENTRE,
BOMMANAHALLI, HOSUR ROAD,
BANGALORE- 560 068.
2.
NAME OF THE INSTITUTION
THE OXFORD DENTAL COLLEGE,
HOSPITAL AND RESEARCH CENTRE,
BANGALORE- 560068.
3.
COURSE OF THE STUDY AND
SUBJECT
MASTER OF DENTAL SURGERY,
PERIODONTICS.
4.
DATE OF ADMISSION TO
COURSE
09 MAY, 2011
5.
TITLE OF THE TOPIC
INFLUENCE OF GLYCEMIC STATUS ON PERIODONTAL CONDITION AND
SPECIFIC PERIODONTAL PATHOGENS IN CONTROLLED AND
UNCONTROLLED DIABETICS BEFORE AND AFTER SRP.
6.
BRIEF RESUME OF INTENDED WORK
6.1 Need for the Study
Diabetes and periodontal disease are both complex chronic entities that have been proven
to have a bidirectional relationship to one another.1 Periodontitis has been described as the
‘sixth complication of Diabetes’.2 Evidence states that diabetics with periodontal disease
have poorer glycemic control, and the poorer the glycemic control, the greater the extent
of periodontal disease.3
The interaction between the host and the bacteria has been shown to determine the loss of
periodontal attachment and alveolar bone. The deep periodontal pockets thus formed,
provide a suitable environment for anaerobic bacteria to flourish. Diabetes tends to alter
the nature of the host response and can conceivably influence the nature of the
subgingival microflora.
Increased in subgingival periodontal pathogens has been observed in periodontal disease
sites of diabetics, although the specific differences in the microbiota of diabetics and nondiabetics are unclear. Comparison of the microbiota of diabetics and non-diabetics
showed a marked increase in periodontal pathogens, namely, Aggregatibacter
actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia,
Capnocytophaga spp., and Campylobacter rectus in diabetics.4 However, many studies
found no such associations.5
Hence, this study aims to determine the prevalence of specific subgingival
periodontal pathogens in the microflora of individuals with controlled and uncontrolled
Diabetes Mellitus before and after Scaling and Root planing and also assess the effect of
Scaling and Root Planing on Glycemic status.
6.2 Review of Literature

A study where individuals with Diabetes Mellitus were grouped under ‘Good
Control’, ‘Moderate Control’ and ‘Poor Control’, based on their control of blood
glucose levels revealed that a greater number of individuals with ‘Poor Control’
had probing depths greater than 5mm.3

Examination of the microbial levels, microbial incidence and the percent levels of
selected periodontal pathogens in periodontally diseased and non-diseased sites in
a group of 15 individuals with poorly controlled Diabetes Mellitus showed
increased levels of Prevotella intermedia, Prevotella melaninogenica,
Porphyromonas gingivalis, Eikenella corrodens, Fusobacterium nucleatum,
Bacteroides gracilis and Campylobacter rectus was observed at the diseased sites.
A significantly higher percentage of Prevotella intermedia has also been
observed.5

A study comparing the periodontal status and the subgingival microflora of 16
juvenile patients with Diabetes Mellitus patients with that of their non-diabetic
cohabiting healthy siblings, revealed significantly elevated levels of
Porphyromonas gingivalis and Capnocytophaga spp., in juvenile diabetic patients
as opposed to the overall mean by cluster sampling.6

Analysis of the detection rates of 5 putative periodontal pathogens:
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Eikenella
corrodens, Treponema denticola and Candida albicans by Polymerase Chain
Reaction (PCR) between diabetic and non-diabetic individuals revealed that there
was a significant increase of Porphyromonas gingivalis, Eikenella corrodens,
Treponema denticola and Candida albicans in both, the diseased and non-diseased
sites of diabetic individuals.7

An evaluation of 71 diabetic individuals against 141 non-diabetic controls in good
general health for clinical periodontal status and subgingival plaque samples for
Porphyromonas gingivalis, Prevotella intermedia and Tannerella forsythia using
Polymerase Chain Reaction (PCR), demonstrated a significant periodontal
deterioration in individuals with Diabetes Mellitus with fewer teeth present and
more plaque with prevalent Porphyromonas gingivalis and Tannerella forsythia.8

A comparative study between diabetic and non-diabetic individuals using PCR to
detect Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and
Tannerella forsythia showed that the individuals with Diabetes Mellitus did not
harbor more periodontal pathogens than the control subjects.9

A comparison of two groups of individuals having Diabetes Mellitus of which one
group received periodontal therapy, showed that during the 9 month observation
period, there was a 17.1% improvement in the glycemic control in the group that
received periodontal therapy as opposed to the 6.7% improvement in the control
group, a statistically significant difference.10

A clinical trial analyzing the effect of Full Mouth-Scaling and Root-planing
against Partial-Mouth Scaling and Root Planing in individuals with controlled and
uncontrolled Diabetes Mellitus revealed that individuals with Better-controlled
Diabetes achieved a lower mean Clinical Attachment Level at 6 months.11
6.3 Objectives of the Study
1. To establish and compare the prevalence of the subgingival periodontal
pathogens Porphyromonas gingivalis, Prevotella intermedia and
Capnocytophaga spp., in individuals with controlled and uncontrolled
Diabetes Mellitus before and after Scaling and Root-Planing.
2. To compare the clinical periodontal parameters between individuals with
controlled and uncontrolled Diabetes Mellitus before and after Scaling and
Root-Planing.
3. To assess the influence of Scaling and Root-Planing on Glycemic control
in individuals with controlled and uncontrolled Diabetes Mellitus.
7.
MATERIALS AND METHODS
7.1 Source of Data
Patients visiting the Department of Periodontics and the Department of Oral Pathology at
The Oxford Dental College, Hospital and Research Centre, Bommanahalli, Bangalore.
7.2 Method of Collection of Data
Inclusion Criteria

Patients presenting to the clinic having been diagnosed with Diabetes
Mellitus.

No other systemic/medical complications.

Patient should have more than 20 natural teeth.

Age > 18 years.
Exclusion Criteria

Use of antibiotics over the past 3 months.

Patients who have undergone periodontal therapy over the past 6 months.

Use of steroids or other medications that may alter immune response.

Presence of plaque retentive factors.

Tobacco/pan chewers and smokers.

Pregnant and lactating women.

Other systemic diseases/conditions.
7.3 Study Design
40 patients will be divided into 2 groups after their Glycated Hemoglobin levels (HbA1c)
have been established. The first group will comprise of 20 individuals who have
controlled diabetes (HbA1c < 7.0%)12. The second group will comprise of 20 individuals
who have uncontrolled diabetes (HbA1c ≥ 7.0%). The study will be explained to, and an
informed signed consent will be obtained from the patient.
Clinical Examination
The following clinical parameters will be recorded for all the subjects:
1. Plaque Index - Silness and Loe
2. Gingival Index - Loe and Silness
3. Bleeding Index - Ainamo and Bay
4. Periodontal Status:

Probing Pocket Depth (using a Florida Probe™)

Loss of attachment (using a Florida Probe™)
Collection of Plaque Sample and Analysis
2 sites with the deepest probing depths will be chosen from each quadrant. A sterile
Gracey curette will be used to remove the supragingival plaque so that it does not
contaminate the subgingival plaque sample. Undisturbed pooled subgingival plaque
samples will then be collected using another sterile Gracey curette. After collection, the
plaque samples will be placed into capped vials containing the transport medium.
The plaque samples will then be analyzed by Real-Time Polymerase Chain Reaction (qrtPCR) to establish the prevalence of Porphyromonas gingivalis, Prevotella intermedia and
Capnocytophaga spp.
All the subjects will be rendered initial Phase-I therapy and will be advised to follow the
Modified Bass Technique of brushing. The subjects will be recalled after 6-8 weeks and
the Glycated Hemoglobin levels (HbA1c) will be established again, following which, the
above mentioned clinical examinations will be carried out and plaque samples will be
collected from the test sites and analyzed similarly.
The results will be statistically analyzed and compared for the 2 groups using the
following tests:
1. Student’s t test
2. Chi-squared test
3. Fisher’s exact test
The entire study will be completed in 1 year.
7.3 Does the study require any investigation or intervention to be conducted on
patients or other humans or animals?
Yes, samples of the patient’s blood will be analyzed for Glycated Hemoglobin
levels and subgingival plaque samples from the gingival sulcus/periodontal pockets will
be collected for analysis of specific periodontal pathogens before and after Scaling and
Root Planing.
7.4 Has the ethical clearance been obtained from your institution?
Yes, a certificate has been attached.
8.
LIST OF REFERENCES
1. Grossi SG, Genco RJ. Periodontal disease and diabetes mellitus: a two-way
relationship. Ann Periodontol 1998;3:51-61.
2. Loe H. Periodontal disease: the sixth complication of diabetes mellitus.
Diabetes Care 1993;16:329-334.
3. Sastrowijoto SH, Hillemans P, van Steenbergen TJM, Abraham-Inpijn L,
deGraaff J. Periodontal condition and microbiology of healthy and diseased
periodontal pockets in type 1 diabetes mellitus patients. J Clin Periodontol
1989;16:316-322.
4. Hamlet SM, Cullinan MP, Westerman B, Lindeman M, Bird PS, Palmer J.
Distribution of Aggregatibacter actinomycetemcomitans, Porphyromonas
gingivalis and Prevotella intermedia in an Australian population. J Clin
Periodontol 2001;28:1163-1171.
5. Mandell RL, Dirienzo J, Kent R, Joshipura K, Haber J. Microbiology of
healthy and diseased periodontal sites in poorly controlled insulin-dependent
diabetes Mellitus. J Periodontol 1992;63:274-279.
6. Seppala B, Seppala M, Ainamo J. A longitudinal study on insulin-dependent
diabetes mellitus and periodontal disease. J Clin Periodontol 1993;20:161165.
7. Sbordone L, Ramaglia L, Barone A, Ciaglia RN, Iacono VJ. Periodontal
status and selected cultivable anaerobic microflora of insulin-dependent
juvenile diabetics. J Periodontol 1995:452-461.
8. Yuan K, Chang C-J, Hsu P-C, Sun HS, Tseng C-C, Wang J-R. Detection of
putative periodontal pathogens in non-insulin-dependent diabetes mellitus and
non-diabetes mellitus individuals by polymerase chain reaction. J Periodont
Res 2001;36:18-24.
9. Campus G, Salem A, Uzzau S, Baldoni E, Tonolo G. Diabetes and periodontal
disease: a case-control study. J Periodontol 2005;76:418-425.
10. Stewart JE, Wager KA, Friedlander AH, Zaldeh HH. The effect of periodontal
treatment on glycemic control in patients with type 2 diabetes mellitus. J Clin
Periodontol 2001;28:306-310.
11. Santos VR, Lima JA, Mendonca ACD, Maximo MBB, Faveri M, Duarte PM.
Effectiveness of full-mouth and partial-mouth scaling and root planing in
treating chronic periodontitis in subjects with Type 2 Diabetes. J Periodontol
2009;80:1237-1245.
12. American Diabetes Association. Standards of medical care in diabetes—
2010. Diabetes Care 2010;33(suppl):S11-S61.