| CTRI Number |
CTRI/2024/09/073534 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Light Treatment for Pyorrhea in Gums |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial Photodynamic Therapy as an adjunct to Periodontal surgery in intrabony defects: a randomised controlled 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 |
Rameshwari Singhal |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Fifth floor Department of Periodontology KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9837400562 |
| Fax |
|
| Email |
rameshwarisinghal@kgmcindia.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Sharma |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Fifth floor Department of Periodontology KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9837400562 |
| Fax |
|
| Email |
dr.sheetalsharma93618@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rameshwari Singhal |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Fifth floor Department of Periodontology KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9837400562 |
| Fax |
|
| Email |
rameshwarisinghal@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology King Georges medical university, Shahmina Road, Chowk, Lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
Rameshwari Singhal |
| Address |
Department of Periodontology New Dental Building, FODS, King Georges Medical University, chowk Lucknow 226003 |
| 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 Rameshwari Singhal |
King Georges Medical University |
Department of Periodontology, New dental building Fifth floor, FODS, King Georges Medical University
Lucknow
UTTAR PRADESH |
9837400562
rameshwarisinghal@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antimicrobial photodynamic therapy |
non surgical periodotnal therapy + A diode laser used along with a photosensitizer/dye for 3 months . |
| Intervention |
conventional regenerative therapy |
non-surgical periodontal therapy + Traditional debridement of the periodontal pocket for 3 months |
| Comparator Agent |
non-surgical periodontal therapy. |
Periodontal pockets will be treated with only scaling root planing and curettage of the affected sites for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults between 18 to 50 years of age
Bilateral defects with probing depth greater than 5mm and clinical attachment level greater then equal to 6mm associated with an intrabony defect greater than equal to 3mm
Full mouth plaque scores and full mouth bleeding scores 20 percent after non surgical periodontal therapy
Nonsmokers or former smokers who have not smoked within 6 months of study initiation
Vital or root canal treated tooth with no associated endodontic pathology
|
|
| ExclusionCriteria |
| Details |
Patients with clinically significant or unstable systemic diseases or compromised healing potential
Patients with history of antibiotic nonsteroidal antiinflammatory medication or on drug affecting periodontal status for greater than equal to 2weeks prior to enrolment in the study
Pregnant or lactating women
History of periodontal surgery within last one year of enrolment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pocket probing depth clinical attachment loss and MMP1 levels healing dynamics |
Reduction in pocket probing depth clinical attachment loss and MMP1 levels healing dynamics at baseline and 21days 3months and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient perceived satisfaction |
6months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
The present study is planned to understand the role of photodynamic therapy in reducing microbial load and promoting regeneration when used as an adjunct to minimally invasive periodontal surgical procedures in interproximal intra-bony defects and to compare it with the conventional regenerative periodontal surgery. It will be a split mouth randomized controlled trial and will be followed up for a span of 6 months where healthy patients with pocket probing depth greater than or equal to 5mm and clinical attachment loss greater than or equal to 6mm will be enrolled. We shall be assessing the outcomes through various clinical parameters such as pocket probing depth clinical attachment loss plaque index gingival bleeding index wound healing index and other factors like patient perceived satisfaction. It works on the hypothesis antimicrobial photodynamic therapy leads to reduction in pocket probing depth clinical attachment loss and bone fill along with better healing dynamics reduction in microbial load as well as MMP1 compared to conventional regenerative therapy.
|