| CTRI Number |
CTRI/2025/07/091557 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A study for comparison of procedures for increased tooth movement |
|
Scientific Title of Study
|
Comparison of efficacy of Micro-osteoperforation and Piezocision on rate of tooth movement: A split mouth study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Sinha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
7739886071 |
| Fax |
|
| Email |
pallavisinha.ps1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshu Sahu |
| Designation |
professor, head of Department |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
7739886071 |
| Fax |
|
| Email |
anshusahu77@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Sinha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Room number 06, Department of orthodontics and dentofacial orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
7739886071 |
| Fax |
|
| Email |
pallavisinha.ps1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hazaribag college of dental sciences and hospital, NH 33, Demotand, Hazaribag, 825301 |
|
|
Primary Sponsor
|
| Name |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Hazaribag college of dental sciences and hospital, NH 33, Demotand, Hazaribag |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Pallavi Sinha |
Hazaribag College of Dental Sciences and Hospital |
Room number 6, Department of Orthodontics and Dentofacial Orthopedics, Hazaribag College of Dental Sciences and Hospital, NH 33, Demotand, Hazaribag
Hazaribag
JHARKHAND |
7739886071
pallavisinha.ps1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hazaribag College of Dental Sciences and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Micro osteoperforation |
It is a procedure of which accelerates the rate of tooth movement in orthodontic therapy. The effect of this procedure will be monitored for 56 days. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Piezocision |
It is a method to accelerate orthodontic tooth movement using piezo electric knife. The effect of this procedure will be monitored for 56 days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Angles Class I Bimaxillary protrusion indicated all four first premolar extraction
Class II Division 1 malocclusion indicated for bilateral maxillary first premolar extraction
All subjects undergoing treatment with Preadjusted Edgewise mechanotherapy
Subjects who have completed the leveling and alignment
No radiographic evidence of bone loss
No history of periodontal disease
No current active periodontal disease |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases.
Patients who had previously undergone orthodontic treatment.
No missing, supernumerary, or impacted teeth (except mandibular third molars).
Patients with smoking habits.
Poor oral hygiene for more than 2 visits. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of micro osteoperforation and piezocision in accelerating tooth movement |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/08/2025 |
| 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="0"
Days="0" |
|
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
|
AIM - To compare the efficacy of
micro osteoperforation and piezocision on the rate of tooth movement during
orthodontic treatment.
OBJECTIVES-
i.To
evaluate the effect of micro osteoperforation on rate of tooth movement.
ii.To
evaluate the effect of piezocision on rate of tooth movement. The null hypothesis of this study - there is no difference in the effects of piezocision and micro osteoperforation on rate of tooth movement. |