| CTRI Number |
CTRI/2019/06/019508 [Registered on: 03/06/2019] Trial Registered Prospectively |
| Last Modified On: |
23/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF BIOMARKER LEVELS IN PERIODONTITIS PATIENTS WITH TYPE2 DIABETES MELIITUS |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF ENDOCAN AND TNF-ALPHA LEVELS IN CHRONIC PERIODONTITIS PATIENTS WITH TYPE 2 DIABETES MELLITUS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri K |
| Designation |
Postgraduate student |
| Affiliation |
SRM DENTAL COLLEGE,RAMAPURAM |
| Address |
Department of Periodontics and Oral implantology,
SRM DENTAL COLLEGE
Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600 089
India |
| Phone |
9790825289 |
| Fax |
|
| Email |
gayu89kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Ponnaiyan |
| Designation |
Reader |
| Affiliation |
SRM DENTAL COLLEGE,RAMAPURAM |
| Address |
Department of Periodontics and Oral Implantology
SRM DENTAL COLLEGE
Bharathi Salai, Ramapuram,
Chennai
TAMIL NADU
600089
India |
| Phone |
9884358568 |
| Fax |
|
| Email |
deepa_ponnaiyan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri K |
| Designation |
Postgraduate student |
| Affiliation |
SRM DENTAL COLLEGE,RAMAPURAM |
| Address |
Department of Periodontics and Oral Implantology,
SRM DENTAL COLLEGE
Bharathi Salai, Ramapuram
Chennai
TAMIL NADU
600089
India |
| Phone |
9790825289 |
| Fax |
|
| Email |
gayu89kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM DENTAL COLLEGE,
Ramapuram,Chennai
|
|
|
Primary Sponsor
|
| Name |
Gayathri K |
| Address |
Department of Periodontics and Oral Implantology
SRM Dental College,
Bharathi salai,Ramapuram
chennai |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gayathri K |
SRM dental college,Ramapuram |
Deoartment of Periodontics and Oral implantology
Bharathi salai,
Ramapuram
Chennai
TAMIL NADU |
9790825289
gayu89kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM DENTAL COLLEGE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non surgical periodontal therapy in systemically healthy chronic periodontitis patients |
Non surgical periodontal therapy involving scaling and root planning of the periodontally affected teeth. |
| Intervention |
Non surgical periodontal therapy in chronic periodontitis patients with Type 2 Diabetes mellitus (good control patients with HbA1c less than 7% and poor control patients with HbA1c more than 8% |
non surgical periodontal therapy includes scaling and root planning of the periodontally affected teeth. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Minimum number of 15 teeth should be present.
2.Patients with Generalised Chronic periodontitis exhibiting Probing Pocket depth of more than or equal to 4mm with Clinical attachment level of more than or equal to 3mm in more than 30percent of diseased sites, According to the AAP 1999 World Workshop (Group I)
3.If more than five sites satisfy the criteria, sample sites were selected based on greater amount of gingival inflammation, probing pocket depth and clinical attachment level.
4.Chronic periodontitis patient with Type 2 diabetes mellitus exhibiting good and poor control.
According to American Diabetic Association(ADA) classification of glycaemic control-
a) Subjects with HbA1c below 7% , as Type 2 diabetics with good control in one group(group II)
b) Subjects with HbA1c more than 8% , as Type 2 diabetics with poor control in another group(group III)
|
|
| ExclusionCriteria |
| Details |
1.Patients with other systemic condition or diseases influencing the course of periodontal disease other than diabetes.
2.Patients with haemoglobinopathies, bleeding and clotting disorders that will influence HbA1c level.
3.History of periodontal treatment within the previous six months
4.Antimicrobial therapy immunosuppressants or lipid lowering drugs within the past 3months
5.Current Smokers who have smoked more than or equal to 100 cigarettes in their lifetime and currently smoke,Former smokers have smoked more than or equal to 100 cigarettes
6.Heavy alcoholics
7.Pregnancy and Lactation |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in systemically healthy Chronic Periodontitis subjects
2.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with well controlled diabetes mellitus (HbA1C less than 7).
3.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with poorly controlled diabetes mellitus (HbA1C more than 8).
|
At baseline and after 3months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the levels of Endocan and TNF-alpha between study groups.
2.To Correlate Endocan and TNF-alpha levels with the periodontal clinical parameters in all the groups before and after non-surgical periodontal therapy
|
At baseline and at 3months |
|
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Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2019 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Tumour Necrosis Factor alpha is an established pro inflammatory marker in periodontal disease. However till date there have been no studies evaluating Endocan as a diagnostic and prognostic marker in periodontitis with Type 2 diabetes mellitus. Endocan is expressed in the initial stages of periodontal inflammation and expected decreased after the non surgical periodontal therapy. Thus it is hypothesized that Endocan levels will be increased in periodontitis subjects with Type2 diabetes mellitus . Based on this ,If the hypothesis works ,Endocan can be used as a potent prognostic marker and a novel chair side diagnostic assay in periodontal disease diagnosis especially in Type 2 Diabetics subjects.
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