FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104116 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Fluoride Mouth rinse and Chlorhexidine for Prevention of white spot lesions during fixed Orthodontic treatment 
Scientific Title of Study   Comparison of Fluoride Mouth rinse and Chlorhexidine for prevention of white spot lesions during fixed orthodontic treatment: Prospective blinded 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 Awanindra Kumar Jha 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Room No-8 Orthodontics and Dentofacial Orthopaedics Dental Institute RIMS Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  8676054766  
Fax    
Email  drakjha007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Awanindra Kumar Jha 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Room No-8 Orthodontics and Dentofacial Orthopaedics Dental Institute RIMS Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  8676054766  
Fax    
Email  drakjha007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Awanindra Kumar Jha 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Room No-8 Orthodontics and Dentofacial Orthopaedics Dental Institute RIMS Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  8676054766  
Fax    
Email  drakjha007@gmail.com  
 
Source of Monetary or Material Support  
Multidiscipinary Research Unit RIMS 
 
Primary Sponsor  
Name  Multidisciplinary Research UnitMRU Rajendra Institute of Medical Sciences 
Address  Multidisciplinary Research Unit, Rajendra Institute of Medical Sciences,Bariatu,Ranchi-834009 
Type of Sponsor  Government funding agency 
 
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 Awanindra Kumar Jha  Dental Institute  Room no-8,Dept. of Orthodontics, Dental Institute, Rajendra Institute of Medical sciences, Bariatu
Ranchi
JHARKHAND 		 7004822617

drakjha007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine Mouthrinse  Chlorhexidine Mouthrinse at night time after dinner for Six Month 
Intervention  Fluoride Mouth rinse  Fluoride Mouth rinse at night time after dinner for six month 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. The patient appointment given for fixed orthodontic treatment.
2. The patient having age group of 14 to 25, having good oral hygiene.
3. The patient having no habit of smoking with no systemic medical condition.
 
 
ExclusionCriteria 
Details  1. Those patients received previous orthodontic treatment.
2. More than 2 carious cavity
3. Enamel abnormality prior to treatment
4. Any Pregnant female or Mentally retarded patient
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be estimation of White spot lesion on patient level assessed from digital photographs.
The white spot lesion index9 (Gorelick et al,1982)
0-No visible white spot lesion (No demineralization)
1-Visible WSL that covered less than 1/3rd of the tooth surface.(Mild demineralization)
2-Visible WSL that covered more than 1/3rd of the tooth surface, with a roughened surface.(Moderate demineralization)
3-Visible cavitations requiring restoration.( Severe demineralization)
 		 6 month of orthodontic treatment with use of mouthrinse at night time.
 
 
Secondary Outcome  
Outcome  TimePoints 
Bleeding from Gum  6 month of Fixed orthodontic Treatment 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   02/03/2026 
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="1"
Months="0"
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 present study will be planned to know the efficacy of Fluoride mouth rinse in prevention of white spot lesion in patients undergoing fixed multibracket orthodontic treatment. The present study will be to know which is better mouth rinse for prevention of white spot lesion in patient undergoing fixed multi-bracket orthodontic treatment. The oblective of trial is to determine efficacy of mouthrinse in reduction of white spot lesion. 
Close