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CTRI Number  CTRI/2025/02/080178 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   The Effects of Riboflavin Photodynamic Therapy after cleaning on teeth and their surrounding structures of patients undergoing braces treatment 
Scientific Title of Study   Comparative Evaluation of the Effects of Riboflavin Photodynamic Therapy as an Adjunct to Ultrasonic Scaling on Periodontal Health in Orthodontic Patients: A Split-Mouth Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Javed Sodawala 
Designation  Professor and Head 
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Dept. of Orthodontics, Chhattisgarh Dental College and Research Institute, Sundara, GE Road, Rajnandgaon, Chhattisgarh - 491441

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000858658  
Fax    
Email  drjavedazher@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ranjit H Kamble 
Designation  Professor and Head 
Affiliation  Sharad Pawar Dental College 
Address  Dept. of Orthodontics, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra - 442004

Wardha
MAHARASHTRA
442004
India 
Phone  9822231975  
Fax    
Email  ranjitkamble2506@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Javed Sodawala 
Designation  Professor and Head 
Affiliation  Chhattisgarh Dental College and Research Institute 
Address  Dept. of Orthodontics, Chhattisgarh Dental College and Research Institute, Sundara, GE Road, Rajnandgaon, Chhattisgarh - 491441

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7000858658  
Fax    
Email  drjavedazher@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Orthodontics, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra - 442004 
 
Primary Sponsor  
Name  Dr Javed Sodawala 
Address  Dept of Orthodontics, Chhattisgarh Dental College and Research Institute, Sundara, GE Road, Rajnandgaon, Chhattisgarh - 491441 
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 
Dr Javed Sodawala  Sharad Pawar Dental College  Room no. 102, Dept of Orthodontics, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra - 442004
Wardha
MAHARASHTRA 		 7000858658

drjavedazher@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of DMIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Riboflavin photodynamic therapy  Riboflavin photodynamic therapy will be performed in experimental group at first visit (T0), after 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4) and 5 months (T5) after ultrasonic scaling.  
Comparator Agent  Ultrasonic scaling  Ultrasonic scaling will be performed in both the experimental and control group at first visit (T0), after 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4) and 5 months (T5). 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients who can follow specific brushing techniques as instructed by the researcher.
Patients undergoing fixed orthodontic treatment from at least 6 months.
Patients with Gingival index greater than or equal to 1.1, Plaque index greater than or equal to 1 and Bleeding on probing greater than or equal to 1.
Patients without oral lesions.
Patients who are willing to sign informed consent (self/parent/guardian). 
 
ExclusionCriteria 
Details  Individuals with special needs.
Patient with adverse oral habits such as smoking, tobacco chewing, nail biting.
Patients with systemic conditions like diabetes, immune system disorders, glucose-6-phosphate dehydrogenase deficiency or under drugs like anti-depressants- monoamine oxidase inhibitors (MAOIs), antiseptic mouthwash, corticosteroid or immunosuppressant drugs which affects the gingiva.
Patients with history of previous periodontal treatment, antibiotic or anti-inflammatory therapy received in the 3 months immediately prior to treatment or during treatment.
Pregnant or lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Gingival Index
2. Plaque Index
3. Pocket Depth
4. Bleeding on Probing 		 At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain and Discomfort
2. Adverse Effects or Complications
3. Cost-Effectiveness
4. Clinical and demographic differences 		 At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6). 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   18/02/2025 
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 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  

Riboflavin can be used as a photosensitizer agent for antimicrobial photodynamic therapy in the field of orthodontics. There are no clinical studies regarding this subject at present. To overcome these lacunae in the literature, a prospective split-mouth randomized controlled trial will be designed to evaluate the effect of riboflavin photodynamic therapy on periodontal health. Patients undergoing fixed orthodontic treatment will be selected as per eligibility criteria from the Department of Orthodontics and Dentofacial Orthopedics. Ultrasonic scaling will be performed in both the experimental and control groups, followed by riboflavin photodynamic therapy irradiation only in the experimental group at the first visit (T0), and subsequently after 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), and 5 months (T5) after ultrasonic scaling. The Plaque Index, Gingival Index, Bleeding on Probing, and Pocket Depth will be measured at the first visit (T0), after 1 month (T1), 3 months (T3), and 6 months (T6) before receiving photodynamic therapy and compared in both groups.

 
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