| CTRI Number |
CTRI/2025/03/082841 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Use of photodynamic therapy as an adjunct to scaling and root planing in treatment of periodontitis: randomized clinical trial |
|
Scientific Title of Study
|
Use of photodynamic therapy as an adjunct to scaling and root planing in treatment of periodontitis:randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandni Rameshkumar Motwani |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science,Dharmsinh Desai University |
| Address |
Faculty of Dental Science,Dharmsinh Desai University,College Road,Nadiad-387001,Gujarat
Kheda
GUJARAT
387001
INDIA
Kheda
GUJARAT
387001
India |
| Phone |
9978833721 |
| Fax |
|
| Email |
motwaniprem65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasumati Patel |
| Designation |
Professor and Head of Department |
| Affiliation |
Faculty of Dental Science,Dharmsinh Desai University |
| Address |
Faculty of Dental science,Dharmsinh Desai University,College Road,Nadiad-387001,Gujarat
Kheda
GUJARAT
387001
INDIA
Kheda
GUJARAT
387001
India |
| Phone |
8200210769 |
| Fax |
|
| Email |
pateldrvasu@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni Rameshkumar Motwani |
| Designation |
Resident Doctor |
| Affiliation |
Faculty of Dental Science,Dharmsinh Desai University |
| Address |
Faculty of Dental Science,Dharmsinh Desai University,College387001,Gujarat
Kheda
GUJARAT
387001
INDIA
Kheda
GUJARAT
387001
India |
| Phone |
9978833721 |
| Fax |
|
| Email |
motwaniprem65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dharmsinh Desai University |
|
|
Primary Sponsor
|
| Name |
Dharamsinh Desai University |
| Address |
Dharamsinh Desai University,Faculty Of Dental Science,College Road ,Nadiad-387001,GUJARAT |
| Type of Sponsor |
Research institution |
|
|
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 |
| Chandni Motwani |
Dharmsinh Desai University |
Faculty Of Dental Science,
Dharamsinh Desai University,Nadiad,Kheda,Gujarat 387001
Kheda
GUJARAT |
9978833721
motwaniprem65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF FACULTY OF DENTAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A414||Sepsis due to anaerobes, (2) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antimicrobial photodynamic therapy |
aPDT is a non-invasive treatment that uses light to target and eliminate microorganisms. It involves the application of a photosensitizing agent, followed by exposure to a specific wavelength of light. |
| Comparator Agent |
SCALING AND ROOT PLANING- AT BASELINE,15 DAYS,90 DAYS |
SCALING AND ROOT PLANING ALONG WITH ADJUNCTIVE PHOTODYNAMIC THERAPY- AT BASELINE,15 DAYS,90 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS HAVING PERIODONTITIS WITH PROBING DEPTH MORE THAN AND EQUAL TO 4 |
|
| ExclusionCriteria |
| Details |
PREGNANT OR LACTATING WOMEN.
ANY PERIODONTAL THERAPY RECEIVED IN LAST 6 MONTHS.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in bleeding on probing,
Gain in clinical attachment level,Reduction in probing depth |
Day-1,15,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival & plaque index |
Day-1,15,90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In this, randomized cross sectional trial, control group had received only basic periodontal treatment (SRP group). Test group patients underwent scaling and root planing followed by adjunctive PDT. Patients who had received periodontal, antibiotic, or photodynamic treatment in the last 6 months were excluded from the study. The clinical parameters assessed in this study were pocket probing depth (PPD), clinical attachment level (CAL), and plaque index (PI) gingival index (GI).All the data at baseline,15 days and 90 days. Postintervention were taken and tabulated. The methylene blue dye was applied gently inside the pocket of the test group subjects. The methylene blue dye was allowed to remain inside for 60 s. The pocket was irrigated thoroughly with normal saline to clear out any extra dye from the base of the pocket. The laser was applied for 1 min/tooth (10 s for each of the sites) at an energy of 6J/sqcm2 using circular movements enhancing the best activation of the methylene blue dye molecules.
|