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CTRI Number  CTRI/2022/10/046582 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 17/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Assessment of permanent retainer at middle third and incisal third position  
Scientific Title of Study   Assessment of durability, stability & periodontal health of mandibular bonded lingual retainer at different vertical positions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Triparna 
Designation  PG student 
Affiliation  sudha rustagi dental college 
Address  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & RESEARCH, SECTOR - 89, KHERI MORE

Faridabad
HARYANA
121002
India 
Phone  07838895923  
Fax    
Email  triparna162012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR GRUKEERAT SINGH 
Designation  PROFESSOR & HOD DEPARTMENT OF ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 
Affiliation  sudha rustagi college of dental sciences & research 
Address  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & RESEARCH, SECTOR - 89, KHERI MORE

Faridabad
HARYANA
121002
India 
Phone  01294230000  
Fax    
Email  drgurkeeratsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR GRUKEERAT SINGH 
Designation  PROFESSOR & HOD DEPARTMENT OF ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 
Affiliation  sudha rustagi college of dental sciences & research 
Address  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & RESEARCH, SECTOR - 89, KHERI MORE

Faridabad
HARYANA
121002
India 
Phone  01294230000  
Fax    
Email  drgurkeeratsingh@gmail.com  
 
Source of Monetary or Material Support  
Sudha Rustagi College of Dental Sciences & Research, Faridabad 
 
Primary Sponsor  
Name  TRIPARNA KAPOOR 
Address  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & RESEARCH, SECTOR - 89, KHERI MORE, FARIDABAD, HARYANA - 121002 
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 TRIPARNA  SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & RESEARCH  DEPARTMENT OF ORTHODONTICS & DENTOFACIAL ORTHOPEDICS, ROOM NO. 4 , SECTOR - 89, KHERI MORE
Faridabad
HARYANA 		 7838895923

triparna162012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES & 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  Bonded Lingual retainer  Coaxial wire bonded lingual retainer of the dimension 0.0175" inch placed at the junction of incisal and middle one-third( group 1). 
Comparator Agent  Bonded Lingual retainer  Coaxial wire bonded lingual retainer of the dimension 0.0175" inch placed at the junction of middle and gingival one-third (group 2). 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1) Patients undergoing Orthodontic treatment.
2) Patients with no missing or restored mandibular anterior teeth
3) Patients capable of maintaining good oral hygiene.
4) Patients possessing good general health.
5) Patients consenting to be a part of the study 
 
ExclusionCriteria 
Details  1) Mutilated dentition and/or presence of local pathology in region of interest.
2) Patients with missing or restored mandibular anterior teeth
3) Patients not capable of maintaining good oral hygiene.
4) Patients with known allergies.
5) Patients suffering from any systemic disease like diabetes. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Change in durability, stability and periodontal health of the bonded lingual retainer  0,3,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/10/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Objective : The aim of the present study is to evaluate the effects of coaxial bonded lingual retainer on stability, durability and periodontal health when the wire is placed at two different vertical positions over a period of 6 months

Material & methods : A total of 70 Subjects that underwent orthodontic treatment were selected and bonded lingual retainers will be placed after active orthodontic treatment was over. The patients will be divided into 2 groups; Group 1 (N=35) : coaxial wire BLR positioned at the junction between incisal one-third & middle one-third, Group 2 (N=35) : coaxial wire BLR positioned at the junction between middle one-third & gingival one-third. Follow-up appointments will be made at 3 months(T1) and 6 months(T2).

Results & Conclusion : Awaited

 
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