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CTRI Number  CTRI/2025/10/096048 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing stability of treatment results of participants with two different interventions in the form of two different designs of retention plates after completion of treatment with braces. 
Scientific Title of Study   COMPARISON OF EFFICACY OF HAWLEY VERSUS VACUUM FORMED RETAINERS IN RELATION TO STABILITY OF TREATMENT, PERIODONTAL HEALTH, COMPLIANCE AND COMFORT: A RANDOMISED CLINICAL TRIAL  
Trial Acronym  not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kritika Chauhan  
Designation  Student ,MDS ORTHODONTICS 
Affiliation  JN Kapoor DAV (C) Dental college and hospital  
Address  Department of orthodontics, room no. 7 .JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Department of orthodontics room no.7.JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Yamunanagar
HARYANA
135001
India 
Phone  8544749946  
Fax    
Email  kritikachauhan320gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Zarina Bali  
Designation  Professor, MDS ORTHODONTICS 
Affiliation  JN Kapoor DAV (C) Dental college and hospital  
Address  Department of orthodontics,room no.7JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Department of orthodontics room no.7 JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Yamunanagar
HARYANA
135001
India 
Phone  9416081304  
Fax    
Email  zarinarishi.zb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Zarina Bali  
Designation  Professor,MDS ORTHODONTICS 
Affiliation  JN Kapoor DAV (C) Dental college and hospital  
Address  Department of orthodontics room no.7,JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Department of orthodontics room no.7,JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Yamunanagar
HARYANA
135001
India 
Phone  9416081304  
Fax    
Email  zarinarishi.zb@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  J.N. Kapoor DAV (c) dental college and hospital 
Address  J.N.Kapoor DAV (c) Dental college and hospital , Model town ,Yamunanagar, Haryana,INDIA  
Type of Sponsor  Other [private dental college ] 
 
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 Zarina Bali   JN KAPOOR DAV (C) DENTAL COLLEGE AND HOSPITAL ,YAMUNANAGAR  Department of orthodontics room no.7 JN Kapoor DAV (C) DENTAL COLLEGE AND HOSPITAL ,MODEL TOWN , YAMUNANAGAR, HARYANA , INDIA
Yamunanagar
HARYANA 		 9416081304

zarinarishi.zb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee ,J.N. KAPOOR DAV CENTENARY Dental College , Yamunanagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  post orthodontic treatment follow up for 6 months.  
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hawleys retainer   As there will be two arms of the trial. One group will include subjects receiving hawleys retainers which is the comparator arm of trial. 
Intervention  vacuum formed retainers   it is a two arm parallel clinical trial. One arm of the trial will include subjects receiving vacuum formed retainers which is the intervention arm of the trial  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. North Indian healthy young adult subjects with18-25 years of age.
2. Patients with completed fixed orthodontic treatment within past 7 days of enrolment.
3. Literate subjects with good understanding of English and Hindi language.
4. Subjects with the willingness to participate in the study.
 
 
ExclusionCriteria 
Details  1. Subjects with altered mental status, cognitive disorders and craniofacial anomalies (cleft lip and palate and other syndromes).
2. Patients with the habit of smoking/ chewing tobacco, alcohol abuse etc.
3. Subjects refusing to participate in the study
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out which retainer out of the two (Hawley v/s vacuum formed retainer) is better in terms of stability of intercanine width, intermolar width,alingment,arch length and periodontal health in each group and their comparison   T0- baseline (0-7days after debonding)
T1- 1 month after baseline
T2- 3 months after baseline
T3- 6 months after baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
To find out which retainer out of the two (Hawley v/s vacuum formed retainer) is better in terms of better tolerance by patients and is better at providing good oral health related quality of life in patients.  T0- baseline (0-7days after debonding)
T1- 1 month after baseline
T2- 3 months after baseline
T3- 6 months after baseline
 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 1 
Date of First Enrollment (India)   27/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM- : Comparison of efficacy of Hawley versus vacuum formed retainers in relation to stability of treatment, periodontal health, oral health related quality of life, patient compliance and comfort.

OBJECTIVES-

Primary objective:

1.     Comparison of efficacy of Hawley v/s vacuum formed retainers in relation to the stability and maintenance of treatment results.

2.     Comparison of efficacy of Hawley v/s vacuum formed retainers in relation to maintenance of periodontal health.

Secondary Objective:

1.     To compare oral health related quality of life in patients wearing Hawley v/s vacuum formed retainers.

2.     To compare the compliance and comfort of patients with Hawley v/s vacuum formed retainers.

 

Objective

Outcomes

Method of measurement

1.

To compare efficacy of Hawley v/s vacuum formed retainers in relation to the maintenance and stability of treatment results

To see whether treatment results are maintained to a similar extent with both type of retainers

·        Little’s irregularity index

·        Intercanine, intermolar width assessment

·         Arch length

 

2.

To Compare efficacy of Hawley v/s vacuum formed retainers in relation to maintenance of periodontal health.

 

To see whether the periodontal health is maintained better with one type of retainer in comparison to another

·        Gingival index

·        Plaque index

·        Calculus index

3.

To compare oral health related quality of life of patients wearing Hawley v/s vacuum formed retainers.

 

To check the patient’s perception with both type of retainers in terms of OHRQoL.

·        OHIP-14 questionnaire

4.

To compare the compliance and comfort of patients with Hawley v/s vacuum formed retainers.

 

To see which retainer is more comfortable and better accepted by the patients.

·        Questionnaire

 

Null Hypothesis

 

The null hypothesis of the present study is that there is no difference between Hawley and vacuum formed retainers in relation to stability of treatment results, maintaining periodontal health, OHRQoL of patients and both retainer types are equally comfortable without any difference in patients’ compliance in regard to wearability by patients.

 
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