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CTRI Number  CTRI/2021/03/032110 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effects of Essix and Modified Essix retainer on final teeth positioning 
Scientific Title of Study   To compare occlusal settling and patient compliance between two differently designed vaccum formed retainer -A randomized controlled clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Heli Dholakia 
Designation  PG Student 
Affiliation  Maharaja Krishnakumarsinhji Bhavnagar University 
Address  Department of Orthodontics Manubhai Patel Dental College Vishwajyoti ashram Near vishwamitri bridge Opp. Gujarat mahindra tractor Vadodara GUJARAT 390011 India

Vadodara
GUJARAT
390011
India 
Phone  7984425982  
Fax    
Email  helidholakia93182@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpesh Patel 
Designation  Head of Department  
Affiliation  Maharaja Krishnakumarsinhji Bhavnagar University 
Address  DEPARTMENT OF ORTHODONTICS Manubhai Patel Dental College Vishwajyoti Ashram Near Vishwamitri Bridge Opp. Gujarat Mahindra Tractor Vadodara GUJARAT 390011 India

Vadodara
GUJARAT
390011
India 
Phone  9898107502  
Fax    
Email  dr_kalpeshp@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Heli Dholakia 
Designation  PG Student 
Affiliation  Maharaja Krishnakumarsinhji Bhavnagar University 
Address  40 Maheshwar society Opp Baroda prestige Varacha road Surat Gujarat 395006

Surat
GUJARAT
395006
India 
Phone  7984425982  
Fax    
Email  heli_dholakia@yahoo.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopaedics Manubhai Patel Dental College Vishwajyoti ashram Near vishwamitri bridge Opp. Gujarat mahindra tractor Vadodara Gujarat 390011 India 
 
Primary Sponsor  
Name  Dr Heli Dholakia 
Address  Department of Orthodontics Manubhai Patel Dental College Vishwajyoti ashram Near vishwamitri bridge Opp. Gujarat mahindra tractor Vadodara Gujarat 390011 India 
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 Heli Dholakia  Manubhai Patel Dental College, Vadodra  Department of Orthodontics and Dentofacial Orthopaedics Manubhai Patel Dental College Vishwajyoti ashram Near vishwamitri bridge Opp. Gujarat mahindra tractor Vadodara 390011 Gujarat India
Vadodara
GUJARAT 		 7984425982

helidholakia93182@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHARAJA KRISHNA KUMARSINHJI BHAVNAGAR UNIVERSITY ETHICS COMMITTEE FOR MDS COURSE AND DENTAL RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Essix Retainer  After completion of fixed orthodontic treatment, patients will be given Essix retainer to were in maxillary arch. Patients impression and bite registration will be taken at time of retainer delivery, 3 months and 6 months of retention, at 3 months and 6 months a questionnaire will also be given to patients to fill up. 
Comparator Agent  Modified Essix Retainer  After completion of fixed orthodontic treatment, patients will be given Modified Essix retainer to were in maxillary arch. Patients impression and bite registration will be taken at time of retainer delivery, 3 months and 6 months of retention, at 3 months and 6 months a questionnaire will also be given to patients to fill up. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients who give consent for the proposed study
2. Patients who have undergone fixed orthodontic treatment.
3. Patients who have completed their orthodontic treatment and are in retention phase of treatment. 4. Patients who are systemically healthy. 
 
ExclusionCriteria 
Details  1.Patients having craniofacial or Dentofacial
Syndromes.
2. Patients treated for anterior open bite.
3. Patients suffering from diabetes.
4. Patients having habit of smoking.
5. Patients who are suffering from periodontal disorder.
6. Non-compliant patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in occlusal contacts and change in patient compliance  At Time of retainer Delivery, 3 months of retention and 6 months of retention 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   23/03/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Minimum 72 subjects will be included in this study.
1. Group 1: 36 subjects in Essix Retainer group
2. Group 2: 36 subjects in Modified Essix Retainer retainer group.
·          Randomization: For randomization participants will be randomly allocated to both groups.

Subjects who have completed their orthodontic treatment will be included in this study. Essix Retainer will be constructed as per the design. Modified Essix Retainer will be constructed as per the design. All the retainers will be made by single person. Lingual fixed retainers will be bonded in lower arch . The patients will be instructed to wear the retainers 24 hours a day for 6 months, excluding while eating and brushing their teeth. All necessary instructions about wear and maintenance will be given. All participants will be recalled to take records at following time intervals:
(1) At retainer Delivery [T0]
(2) At 3 months[T1]
(3) At 6 months[T2]
Maxillary alginate impressions and a vinyl polysiloxane bite will be registered each time. Occlusal contacts will be measured on registered bite. Occlusal contacts will be classified as : -
1) True contacts : Points where material is perforated.
2) Near contacts : Translucent points where the thickness less than 0.20mm.
Both types of contacts will be considered. Patient compliance will be assessed by Questionnaire at 3 months and 6 months of retainer delivery.
 
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