| CTRI Number |
CTRI/2024/07/070769 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Microbial comparison of diode laser therapy and curcumin gel therapy with scaling and root planing in Type II Diabetes patients with chronic periodontitis
|
|
Scientific Title of Study
|
Comparative evaluation of adjunctive antimicrobial photodynamic therapy and adjunctive curcumin gel application with Scaling and Root Planing in Type II Diabetes patients with
chronic periodontitis: A clinical and microbiological study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal G Naik |
| Designation |
Post Graduate 1st year MDS |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 3, Dept of
Periodontology, 2nd
floor, The Oxford Dental
College ,
Bommanahalli,
Bangalore Karnataka -
560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8105821853 |
| Fax |
|
| Email |
sheetalgnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. BS Jagadish Pai |
| Designation |
Professor and HOD Periodontology |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 3, Dept of
Periodontology, 2nd
floor, The Oxford Dental
College ,
Bommanahalli,
Bangalore Karnataka -
560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9448163710 |
| Fax |
|
| Email |
bsjpai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal G Naik |
| Designation |
Post Graduate 1st year MDS |
| Affiliation |
The Oxford Dental College, Bangalore |
| Address |
Room no - 3, Dept of
Periodontology, 2nd
floor, The Oxford Dental
College ,
Bommanahalli,
Bangalore Karnataka -
560068
Bangalore
KARNATAKA
560068
India |
| Phone |
8105821853 |
| Fax |
|
| Email |
sheetalgnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College and Hospital, Bommanahalli, Bangalore, Karnataka - 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Sheetal G Naik |
| Address |
Room no - 3, Dept of
Periodontology, 2nd
floor, The Oxford Dental
College ,
Bommanahalli,
Bangalore Karnataka -
560068 |
| 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 |
| Dr Sheetal G Naik |
The Oxford Dental College |
Room no - 3, Dept of
Periodontology, 2nd
floor, The Oxford Dental
College ,
Bommanahalli,
Bangalore Karnataka -
560068
Bangalore
KARNATAKA |
8105821853
sheetalgnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, THE OXFORD DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non surgical periodontal therapy ( Scaling ) |
NSPT is done using piezo ultra-sonic scaler. Porphyromonas gingivalis quantity is detected at the baseline and after 3 months. |
| Intervention |
NSPT and Curcumin gel application against NSPT and antimicrobial photodynamic therapy |
NSPT is done using piezo
ultra-sonic scaler. Curcumin gel is applied at one site. Antimicrobial photodynamic therapy conducted using indocyanine green at another site. Porphyromonas gingivalis quantity is detected at baseline and after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Both male and female patients with the age from 35 -65yrs.
• Both males and females diagnosed with T2DM (classification based on American Diabetes Association classification 2019): -
 Fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hr or
 random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) or
 Glycated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol)
• Presence of Minimum of 20 natural teeth.
• Patients diagnosed with Chronic periodontitis (stage III grade B) with PPD ≥ 6mm and (clinical attachment loss) CAL ≥ 5mm upon periodontal examination. (Classification based on 2017 World Work Shop)
|
|
| ExclusionCriteria |
| Details |
• Patients with any underlying systemic disease other than diabetes.
• Pregnant and lactating women.
• Patients on antibiotic therapy and anti- inflammatory therapy the last 3 months.
• Patients with smoking habit.
• Significant changes in diabetes during the study period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Porphyromonas gingivalis quantity in subgingival plaque sample |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of curcumin and photodynamic therapy on gingival inflammation |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized , parallel group trial showing the effect of Non surgical periodontal therapy and curcumin gel application versus antimicrobial photodynamic therapy on the quantity of porphyromonas gingivalis in the subgingival plaque sample on Type 2 diabetes with chronic periodontitis patients. It will be conducted in The Oxford Dental College , Bangalore in India and the duration for the completion of study will be 3 months. The primary outcome measure will be Porphyromonas gingivalis quantity in subgingival plaque sample before and after NSPT, NSPT and curcumin gel therapy versus NSPT and antimicrobial photodynamic therapy following 3 months. The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss before and after NSPT and curcumin gel therapy versus antimicrobial photodynamic therapy following 3 months. |