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CTRI Number  CTRI/2022/04/042323 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Oral cell changes due to use of fluoride while undergoing orthodontic treatment 
Scientific Title of Study   Effect of fluoride on the cytotoxicity of buccal mucosa cells in the presence of nickel-titanium archwires during comprehensive orthodontic treatment: A randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mayur Bhola 
Designation  Junior Resident 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Dentistry AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9990921867  
Fax    
Email  mb.bhola@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kumar Jena 
Designation  Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Dentistry AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884077  
Fax    
Email  dent_ashok@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Mayur Bhola 
Designation  Junior Resident 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Dentistry AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9990921867  
Fax    
Email  mb.bhola@gmail.com  
 
Source of Monetary or Material Support  
AIIMS bhubaneswar Sijua, Patrapada Bhubaneswar Odisha-751019 
 
Primary Sponsor  
Name  Mayur Bhola 
Address  Department of Dentistry AIIMS, Bhubaneswar Sijua, Patrapada Bhubaneswar 
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 
Mayur bhola   Department of dentistry, AIIMS bhubaneswar   Department of dentistry AIIMS bhubaneswar Sijua, Patrapada Bhubaneswar
Khordha
ORISSA 		 9990921867

mb.bhola@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee AIIMS bhubaneswar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Healthy volunteers  No orthodontic treatment will be carried out. Fluoridated mouthwash and toothpaste will be prescribed. Subjects will be assessed for a period of three months. 
Intervention  Nickel titanium archwire and stainless steel brackets  Nickel titanium archwires will be ligated to stainless steel brackets. Fluoridated mouthwash and toothpaste will be prescribed. Subjects will be assessed for a period of three months following which they will be continued with regular orthodontic treatment for correction of their malocclusion. 
Comparator Agent  Stainless steel brackets  Only stainless steel brackets will be placed. Fluoridated mouthwash and toothpaste will be prescribed. Subjects will be assessed for a period of three months following which they will be continued with regular orthodontic treatment for correction of their malocclusion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Healthy subjects with minimum crowding or spacing in maxillary and mandibular arches.
2. Presence of full complement of teeth except for 3rd molars.
3. Good oral hygiene (Oral Hygiene Index-Simplified Score < 1.2). 
 
ExclusionCriteria 
Details  1. History of orthodontic treatment.
2. Subject who fails to maintain good oral hygiene during study period.
3. Subjects with pregnancy.
4. Subjects having any known syndrome or metabolic disorder affecting salivary glands.
5. Subjects with any oral premalignant disorders. 6. Subjects with metallic restoration or prosthesis.
7. Subjects with occupational exposure to metals. 8. Subjects on long-term medications like NSAIDs or steroids.
9. Subjects with known allergy to nickel.
10. Lack of manual dexterity.
11. Any medications for a systemic illness.
12. History of recent bacterial or viral infection.
13. Subjects who smoke or consume alcohol.
14. Subjects not willing to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cell viability percentage  Cell viability percentage measured at 0 and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Cell micronucleus scoring of buccal mucosa cells  Cell micronucleus scoring at 0 and 3 months. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2022 
Date of Study Completion (India) 04/12/2023 
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)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 21-12-2023 and end date provided 22-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The comprehensive orthodontic treatment utilizes brackets and archwires for the correction of malocclusion. Archwires transmit forces to the tooth via brackets causing movement of the tooth in the desired direction. Enamel white spot lesions are a common iatrogenic outcome of orthodontic treatment. Fluoride-containing mouthwash and toothpaste are routinely recommended to prevent white spot lesions. Fluoride may enhance the corrosion of bracket and archwire alloys. Corrosion products released from these archwires may have cytotoxic effects on the buccal mucosa cells.
Thus, the current study is planned to evaluate the effect of fluoride on the cytotoxicity of buccal mucosa cells in the presence of nickel-titanium archwires during comprehensive orthodontic treatment.

 
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