| CTRI Number |
CTRI/2024/08/072248 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Other (Specify) [PHOTODYNAMIC THERAPY] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF THE EFFECT OF TWO LIGHT BASED TREATMENT WITH ROUTINE GUM SURGERY FOR GUM DISEASES. |
|
Scientific Title of Study
|
Comparative evaluation of the effect of Photodynamic therapy and Photoablation as an adjunct to Open Flap Debridement in periodontitis patients– A Double Blinded Randomized 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 |
Dr. Raghavendra Metri |
| Designation |
Professor |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research dental college Latur. |
| Address |
Room no. 10 First floor, Department of Periodontology, Maharashtra Institute of Dental Sciences and
Research dental college Latur, MAHARASHTRA 413 512 India.
Latur
MAHARASHTRA
413512
India |
| Phone |
9765798877 |
| Fax |
|
| Email |
drmetriraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehal Jadhav |
| Designation |
PG Student |
| Affiliation |
MIDSR Dental college |
| Address |
Dept. of periodontology , MIDSR Dental College , Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9867222042 |
| Fax |
|
| Email |
drsnehalperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra Metri |
| Designation |
Professor and PG guide |
| Affiliation |
MIDSR Dental college |
| Address |
Dept. of periodontology , MIDSR Dental College , Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9765798877 |
| Fax |
|
| Email |
drmetriraghu@gmail.com |
|
|
Source of Monetary or Material Support
|
| MIDSR Dental College, Vishwanathpuram, latur-Ambejogai road , Latur-413512 |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Jadhav |
| Address |
Room no. 10 First floor, Department of Periodontology, Maharashtra Institute of Dental Sciences and
Research dental college Latur, MAHARASHTRA 413512 India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Raghavendra Metri |
Maharashtra Institute of Dental Science and Research , Latur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Jadhav |
Maharashtra Institute of Dental Science and Research |
Room no. 10 First floor,
Department of
Periodontology,
Maharashtra Institute of
Dental Sciences and
Research dental
college Latur,
MAHARASHTRA 413512 India.
Latur
MAHARASHTRA |
9867222042
drsnehalperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharashtra Institute of Dental Science and Research, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open flap debridement |
Open flap debridement for removal of calculus and granulation tissue. For 3 and 6 months follow-up total duration of study inclusive of all the patients will be 1 year 6 months. |
| Intervention |
Photoablasion |
Photoablation using 980 nm diode laser for 10 seconds on the flap adjacent to each tooth. For 3 and 6 months follow-up total duration of study inclusive of all the patients will be 1 year 6 months. |
| Intervention |
Photodynamic therapy |
After copious irrigation with methylene blue dye for 3 minutes, Photodynamic therapy using 650 nm diode laser will be performed on the flap adjacent to each tooth for 10 seconds per tooth . For 3 and 6 months follow-up total duration of study inclusive of all the patients will be 1 year 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants aged between 18 to 55 years.
2) Patients requiring flap surgery for at least a quadrant (5 ≤ PPD ≤ 7) after phase I therapy.
3) ASA I and II
4) Patients willing to comply with the study protocol and follow-up visits.
5) Patients with signed informed consent forms.
|
|
| ExclusionCriteria |
| Details |
1) Individuals with poor oral hygiene {Plaque Index (PI) ≥1} on day of follow up after phase I therapy.
2) Patient’s teeth with more than grade II mobility and grade III and IV furcation involvement.
3) Patients with a history of antibiotic therapy within the last 3 months.
4) Patients with previous surgical periodontal treatment within the last 6 months.
5) Patients who smoke or use any form of tobacco products.
6) Patients who are Pregnant or lactating.
7) Patients with a history of allergy or sensitivity to Methylene blue dye
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of open flap debridement (OFD), open flap debridement with photodynamic therapy (PDT), and open flap debridement with photoablation (PA) in managing periodontitis patients by evaluating the reduction in probing pocket depth (PPD) and gain in clinical attachment level (CAL) at baseline, 3 months and 6 months post-surgery.
|
Baseline, 3 months and 6 months post-surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of open flap debridement (OFD), open flap debridement with photodynamic therapy (PDT), and open flap debridement with photoablation (PA) in managing periodontitis patients by evaluating the reduction in bleeding on probing (BOP) and plaque index (PI), gingival index (GI) at baseline, 3 months and 6 months post-surgery. |
baseline, 3 months and 6 months post-surgery. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The comparative effect of lasers in surgical periodontal treatment using photodynamic therapy and photoablasion is unclear with insufficient data.The purpose of this study is to compare and evaluate the adjunctive benefits of a diode laser to conventional surgical debridement in the treatment of periodontitis, testing the hypothesis that adjunctive use of photodynamic or photoablation therapy to open flap debridement can improve outcomes of surgical periodontal therapy. |