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CTRI Number  CTRI/2026/02/102945 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “How light-based dental treatment affects gum health, blood sugar control, and inflammation in people with type 2 diabetes who have gum disease.” 
Scientific Title of Study   Effects of photodynamic therapy on periodontal parameters and levels of HbA1c and hs-CRP in periodontitis patients with type 2 diabetes mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PERIO/04/232474/RAC  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRiddhi Verma 
Designation  Post graduate student 
Affiliation  Sardar Patel Post Graduate Institute Of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of dental and medical sciences department number 7 Department of periodontology.
Chaudary Vihar Utrathia
Lucknow
UTTAR PRADESH
226029
India 
Phone  9415085343  
Fax    
Email  docamitabh74@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amitabh Srivastava 
Designation  Guide, Professor & HOD 
Affiliation  Sardar Patel Post Graduate Institute Of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of dental and medical sciences Chaudary Vihar Utrathia Raebareli Road Lucknow, department of periodontology, department number 7,Lucknow.

Lucknow
UTTAR PRADESH
226029
India 
Phone  9415085343  
Fax    
Email  docamitabh74@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRiddhi Verma 
Designation  Post graduate student 
Affiliation  Sardar Patel Post Graduate Institute Of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of dental and medical sciences Chaudary Vihar Utrathia Raebareli Road Lucknow, department of periodontology, department number 7, Uttar Pradesh.

Lucknow
UTTAR PRADESH
226029
India 
Phone  9415085343  
Fax    
Email  docamitabh74@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Post Graduate Institute of dental and medical sciences Chaudary Vihar Utrathia Raebareli Road Lucknow, department of periodontology, department number 7 Uttar Pradesh 226029 
 
Primary Sponsor  
Name  Dr.Riddhi Verma 
Address  Sardar Patel Post Graduate Institute of dental and medical sciences Chaudary vihar Raebareilly Road Lucknow 226029 Chaudary Vihar Utrathia 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRiddhi Verma  Sardar Patel Post Graduate Institute Of Dental and Medical Sciences  Sardar Patel Post Graduate Institute of dental and medical sciences Chaudary Vihar Utrathia Raebareli Road Lucknow, department of periodontology, department number 7 Uttar Pradesh 226029
Lucknow
UTTAR PRADESH 		 6394133343

drriddhiverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontitis 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Photodynamic therapy  Photodynamic therapy using Diode laser at 970 nm using methylene blue dye 
Comparator Agent  Scalling and Root planing  Ultrasonic scaling using scalers ad then root planing using universal curettes. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with type 2 diabetes mellitus.
2. Patients having generalised periodontitis.
3. Patients with periodontal probing depths ≥5mm and (CAL)Clinical attachment loss ≥ 3mm.
4. Patients aged 30-60 years of age.
5. Established willingness and ability to perform oral hygiene.
6. HbA1c levels ≥ 5.8% and ≤ 7%
 
 
ExclusionCriteria 
Details  i. Systemic conditions that potentially affect periodontal health but are not related to diabetes.
ii. Cigarette smoking
iii. Past three months of antibiotic, anti-inflammatory, or periodontal treatment history.
iv. Notable modifications to the management of diabetes mellitus over the study period.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To observe and correlate the clinical parameters, HbA1c and hs-CRP levels before and after treatment of Periodontitis in type 2 diabetes mellitus patients by SRP alone.
2.To observe and correlate the clinical parameters, HbA1c and hs-CRP levels before and after treatment of Periodontitis in type 2 diabetes mellitus patients by SRP along with Laser assisted photodynamic therapy.
3. To compare both the modalities for the treatment of periodontitis and their effects on levels of HbA1c and hs-CRP in periodontitis patients with type 2 diabetes mellitus.
 		 At Baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To observe clinical parameters and severity of periodontitis at various levels of HbA1c.
2. To observe clinical response to treatment of periodontitis in patients of type 2 diabetes mellitus.
 		 At Baseline
3 months
6 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   14/02/2026 
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="2"
Months="5"
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 levels of HbA1c and hs-CRP in blood is related to Periodontitis and Type 2 diabetes mellitus. Photodynamic therapy as an adjunct to scaling and root planning may have beneficial effects on lowering these parameters and favorable clinical outcomes. 
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