| CTRI Number |
CTRI/2025/03/083402 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Effectiveness of Light Therapy and Metformin Gel Along with Deep Cleaning for Treating Gum Disease: A Clinical Study" |
|
Scientific Title of Study
|
Clinical efficacy of Photodynamic therapy and 1% Metformin gel as an adjunct to scaling and root planing in the treatment of Periodontitis A randomized clinical trial |
| Trial Acronym |
NSPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B SAI PRATHYUSHA |
| Designation |
post graduate |
| Affiliation |
Sree sai dental college and research institute |
| Address |
Department of Periodontology and Oral Implantology Sree Sai Dental College and Research institute Room no 8 Chapuram Srikakulam 532001
Sree sai dental college and research institute, Department of Periodontology and Oral Implantology, Room no 8, Chapuram, srikakulam.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9666439527 |
| Fax |
|
| Email |
saiprathyu.sai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N. Anwesh Reddy |
| Designation |
PROFESSOR |
| Affiliation |
Sree sai dental college and research institute |
| Address |
Sree Sai Dental College and research institute, Department of Periodontology and Oral Implantology, Room no 8, Chapuram Srikakulam 532001
Sree sai dental college and research institute, Department of Periodontology and Oral Implantology, Room no 8, Chapuram, srikakulam 532001
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
6303927456 |
| Fax |
|
| Email |
anweshperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B SAI PRATHYUSHA |
| Designation |
post graduate |
| Affiliation |
Sree sai dental college and research institute |
| Address |
Sree Sai dental college and research institute, Department of Periodontology and Oral Implantology, Room no 8,Chapuram Srikakulam
Sree sai dental college and research institute, Department of Periodontology and Oral Implantology, Room no 8, Chapuram, srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9666439527 |
| Fax |
|
| Email |
saiprathyu.sai@gmail.com |
|
|
Source of Monetary or Material Support
|
| B Sai Prathyusha
Department of Periodontology sree sai dental college and research institute
Sree Sai Dental college and Research Institute |
|
|
Primary Sponsor
|
| Name |
B Sai Prathyusha |
| Address |
Sree sai dental college and research institute, Department of Periodontology and Oral Implantology, Room no 8, Chapuram srikakulam 532001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 B SAI PRATHYUSHA |
sree sai dental college and research institute |
Department of Periodontology and Oral Implantology, Room no 8,chapuram,srikakulam
Srikakulam
ANDHRA PRADESH |
9666439527
saiprathyu.sai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree sai dental college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteers with no Systemic Illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% metformin gel |
Patient is treated with 1%metformin gel along with scaling and root planing
6 months |
| Intervention |
Photodynamic therapy |
Photodynamic therapy along with scaling and root planing was done to the patient
6 months |
| Comparator Agent |
scaling and root planing |
Scaling and root planing alone
6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients with sites showing probing depth 4-6 mm
2.No history of periodontal therapy or
3.use of antibiotics in the preceding 6 months. |
|
| ExclusionCriteria |
| Details |
1.Patients with known systemic disease
2.Known or suspected allergy to Metformin [MF]
3.Patients on systemic MF or other oral antidiabetic therapy.
4.Patients with aggressive periodontitis
5.Use of tobacco in any form and alcoholism
6.Immunocompromised patients.
7.Pregnant or lactating females.
8.If the study reported additional treatments (e.g. Local or systemic
antimicrobial therapy, adjunctive laser therapy, periodontal surgical therapy) other than SRP + aPDT.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical attachment level
Probing pocket depth |
baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oral hygiene index
Gingival index
plaque index
sulcular bleeding index |
baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
07/04/2025 |
| 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="1"
Months="3"
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
|
In this
current Randomized clinical trial, a total number of 25 patients who will be
visiting the outpatient department of Periodontics will be recruited in the
form of a split-mouth design based on the inclusion and exclusion criteria. After obtaining the informed consent, the
patients will be randomly allocated into three groups. Group I will receive
scaling and root planning alone, Group II will receive SRP along with
photodynamic therapy, Group III will receive SRP along with 1% Metformin gel.
• Scaling and root planning will be
done under Local Anesthesia using hand instruments followed by oral hygiene
instructions.
• Photodynamic therapy - The
selected sites will be rinsed with photosensitizer dye (Methylene blue 10
mg/ml.) employing a blunt cannula and excess photosensitizer
is removed after one minute, followed by laser irradiation.
• 1% Metformin gel - The selected sites
were treated with 1% MF (10µL) with the help of a syringe and blunt cannula
directly into the periodontal pocket. Patients were instructed to refrain from
chewing hard or adhesive foods Treated areas should be excluded during
brushing. Usage of any interdental aids for one week should be strictly avoided. |