FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092521 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
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 tooth movement in a recent extraction tooth socket vs healed tooth socket in terms of amount, rate and type of tooth movement in patients requiring extraction for their orthodontic treatment 
Scientific Title of Study   Comparative evaluation of the amount, rate and type of tooth movement during canine retraction between healed versus recent upper premolar extraction site: a split mouth randomised controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Rajput 
Designation  Post graduate student 
Affiliation  Government Dental College and Hospital, Mumbai 
Address  Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai.

Mumbai
MAHARASHTRA
400001
India 
Phone  8454912677  
Fax    
Email  priyarajbbps@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suryakant Powar 
Designation  Head of the Department 
Affiliation  Government Dental College and Hospital, Mumbai 
Address  Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai.
Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai.
Mumbai
MAHARASHTRA
400001
India 
Phone  9967631213  
Fax    
Email  suryakant.powar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Priya Rajput 
Designation  Post graduate student 
Affiliation  Government Dental College and Hospital, Mumbai 
Address  Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai.
Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai.
Mumbai
MAHARASHTRA
400001
India 
Phone  8454912677  
Fax    
Email  priyarajbbps@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Priya Rajput 
Address  Department of Orthodontics and Dentofacial Orthopedics, Government Dental College and Hospital, Mumbai. 
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 Priya Rajput  Government Dental College and Hospital, Mumbai  Room no. 206, second floor, Department of Orthodontics and Dentofacial Orthopedics.
Mumbai
MAHARASHTRA 
8454912677

priyarajbbps@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee Government Dental College and Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M262||Anomalies of dental arch relationship,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention is the extraction of upper first premolar  The study is a split mouth study involving the upper arch of each patient. One side of the upper arch is recent extraction group while the other side is delayed extraction group. In the delayed extraction group the extraction of upper first premolars is delayed by one month as compared to the recent extraction group. 
Comparator Agent  This study is a split mouth study where one side of the arch is the comparator of the other side.  This study involves patients requiring upper first premolar extraction on both sides. On one side the extraction will be done earlier as compared to the other side. The difference in both the tooth extraction timings will be 4 weeks. So, one side the extraction socket will be healed and the other side it will be recently extracted. After this canine retraction will be initiated on both the sides and the tooth movement on both sides will be compared.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients of age ranging between 16-30 years requiring fixed mechanotherapy with
extraction of upper first premolars as part of treatment plan.
Patients with aligned maxillary arches with mild to moderate crowding.
Patients with complete permanent dentition.  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
evaluation of amount, rate and type of tooth movement during canine retraction in a healed versus recent upper premolar extraction site  at the initiation of canine retraction , at one month , two month and three month after initiation of canine retraction . 
 
Secondary Outcome  
Outcome  TimePoints 
evaluation of gingival cleft formation (if any) in both recent and delayed extraction groups  at the beginning of canine retraction and 3 months after initiation of canine tetraction. 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 4 
Date of First Enrollment (India)   14/08/2025 
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="6"
Days="14" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Orthodontic treatment duration depends on several factors like severity of malocclusion, treatment plan (extraction or non-extraction), patient compliance during treatment etc. Specially Extraction case therapy requires 18–24 months. In this treatment, extraction space closure consumes one-third to one-half of orthodontic treatment duration. In adult patients, lengthy orthodontic treatment is often accompanied with periodontal problems such as root resorption, alveolar bone loss, and gingival recession. Lengthy treatment is also responsible for poor patient compliance. Therefore, acceleration of orthodontic treatment becomes a good choice for Orthodontists for harnessing patients and doctor’s interest. Patients are keen for fast treatment due to treatment discomfort, social, and aesthetic concerns. To explore such treatment strategies many studies were conducted. Studies of tooth movement into a recent extraction site found accelerated tooth movement as compared to the site with healed socket. Thus, it was proposed that retraction of a tooth toward a recent extraction site is more advantageous compared to delayed retraction after extraction. Greater adjacent tooth tipping was reported when teeth were moved toward recent extraction sites as compared to healed extraction sites. The increased tipping on the recent extraction side was justified by the increased movement and the apical repositioning of the centre of resistance after adjacent tooth extraction. In contrast to these findings, another study, reported greater tooth retraction velocity into a healed socket than into a recent extraction socket. Also, similar tipping of teeth in both healed and recently extracted premolar sites have been found in some studies. A frequent complication associated with orthodontic space closure, after permanent tooth extraction, is development of a gingival cleft (GC), often also called invagination and infolding of gingiva. Gingival clefts have been reported to develop in about 35% to 100% of the extraction cases and are more frequent in the mandible. Some studies have suggested that gingival cleft development is a frequent finding during orthodontic space closure and seems to occur more frequently with early tooth movement initiation. On the contrary, other studies have found that the incidence of the gingival clefts did not vary in a statistically demonstrable fashion with the amount of time elapsing between tooth extraction and the initiation of orthodontic space closure. Thus, there is no conclusive data about how tooth movement varies in a recent extraction site as compared to a healed extraction site. Therefore, my study aims to evaluate the amount, rate and type of tooth movement during canine retraction in a recent versus healed extraction site of upper first premolar. This study will also be assessing gingival cleft formation in recent versus healed extraction site.

 
Close