| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |