FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064247 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study of folic acid supplementation on gum health in subjects undergoing orthodontic treatment  
Scientific Title of Study   Effect of folic acid supplementation on periodontal status, gingival biotype and keratinized gingival width in subjects undergoing fixed orthodontic therapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Iman Ahmad 
Designation  Junior Resident (MDS) 
Affiliation  Aligarh Muslim University, Aligarh 
Address  Dept of Orthodontics, Dr. Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8171007887  
Fax    
Email  imanahmad97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Tariq 
Designation  Professor 
Affiliation  Aligarh Muslim University, Aligarh 
Address  Dept of Orthodontics, Dr. Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897217840  
Fax    
Email  jmi786jmi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Tariq 
Designation  Professor 
Affiliation  Aligarh Muslim University, Aligarh 
Address  Dept of Orthodontics, Dr. Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9897217840  
Fax    
Email  jmi786jmi@gmail.com  
 
Source of Monetary or Material Support  
Dept of orthodontics, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh 
 
Primary Sponsor  
Name  Dr Iman Ahmad  
Address  Dept of orthodontics, Dr Ziauddin Ahmad Dental College, Aligarh Muslim University, Aligarh 
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 Mohammad Tariq  Dr Ziauddin Ahmad Dental College, Aligarh University Muslim  Department of Orthodontics
Aligarh
UTTAR PRADESH 		 9897217840

jmi786jmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital Aligarh Muslim University, Aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Systemic folic acid supplementation  5 mg folic acid given orally once daily for 4 months to subjects undergoing fixed orthodontic treatment 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Patients having complete permanent dentition and undergoing fixed orthodontic mechanotherapy
2. Planned for premolar extractions in all 4 quadrants, followed by anterior retraction in maxillary and mandibular arches
3. Gingivitis in the anterior region after levelling and alignment stage of treatment (as per AAP 2018 classification)
 
 
ExclusionCriteria 
Details  1. Previous functional orthopaedic and/or fixed orthodontic treatment
2. Destructive periodontal disease and/or gingival recession before treatment
3. Received periodontal treatment within the previous year
4. Iron/vitamin supplement(s) within the previous 6 months
5. Systemic conditions with related medications
6. Pregnancy and lactation
7. Smoking
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Periodontal status, gingival biotype and keratinised gingival width  T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction 
 
Secondary Outcome  
Outcome  TimePoints 
Serum folate estimation  T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction 
Rate of orthodontic tooth movement   T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [imanahmad97@gmail.com].

  6. For how long will this data be available start date provided 15-04-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Fixed orthodontic appliances impede proper oral hygiene, resulting in increased plaque accumulation and patient’s risk of periodontal inflammation. Studies have shown that folic acid supplementation results in significant reduction in gingival inflammation. This study aims to evaluate the effect of systemic folic acid supplementation on the periodontal condition of subjects undergoing fixed orthodontic therapy.  
Close