| CTRI Number |
CTRI/2025/08/092283 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can gentle bone stimulation help braces work faster?A look at one time vs two time treatment |
|
Scientific Title of Study
|
Comparison of effectiveness of one time versus two time piezoperforation on the rate of orthodontic tooth movement:A three arm parallel 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 |
Eranti Saimanogna |
| Designation |
Post Graduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India
Nellore ANDHRA PRADESH 524003 India |
| Phone |
6304018869 |
| Fax |
|
| Email |
saimanoghna@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Singaraju Gowri Sankar |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9440012443 |
| Fax |
|
| Email |
drgowrisankar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mandava Prasad |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India
Nellore ANDHRA PRADESH 524003 India |
| Phone |
9440976666 |
| Fax |
|
| Email |
mandubrunosai231065@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics,
Narayana Dental College and Hospital,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Eranti Saimanogna |
Narayana Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopaedics,
Department of Periodontics,
Chintareddypalem,
Nellore,
524003,
Andhra Pradesh,
India
Nellore ANDHRA PRADESH |
6304018869
saimanoghna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Participants without any intervention at extraction space |
| Intervention |
one time piezoperforation |
three perforations with each perforation 1.5mm diameter,4mm depth,bilaterally at extraction space distal to canine with each perforation spaced 3mm apart verically will be performed one month after extraction |
| Intervention |
two time piezoperforation |
three perforations with each perforation 1.5mm diameter,4mm depth,bilaterally at extraction space distal to canine with each perforation spaced 3mm apart verically,second time piezoperforation was performed at the end of 6th week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Physically and mentally healthy individuals of both genders in the age group of 18-25 years
2.Class I malocclusion with bimaxillary protrusion
3.Class II division 1 malocclusion
4.Crowding 1-3mm assessed by little’s index space requirement showing all four premolar extractions
5.No history of orthodontic treatment
6.Healthy teeth without any active lesions
7.Patients with full permanent dentition
8.Patients without any habit of alcohol intake and smoking
|
|
| ExclusionCriteria |
| Details |
1.Evidence of bone loss or periodontal problems
2.Patients with systemic diseases ,bleeding diathesis
3.Patients taking medication that can interfere with orthodontic tooth movement
4.Extractions other than 1st premolar extraction in the upper arch
5.Crowding greater than 3mm
6.Pregnant patients
7.Patients with removable appliances, additional appliances that could be unpredictable pain sources such as headgear and miniscrew
8.Patients who has undergone orthognathic surgery
9.Missing teeth except for third molars treatment with extractions (impacted or unerupted permanent teeth)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| amount of tooth retraction |
The amount of tooth retraction will be measured at
the 2nd(T1), 4th (T2), 8th (T3), and 12th (T4) weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intensity of perceived pain measured on a 10cm visual analogue scale |
t1-2 hrs after piezoperforation, t2-6 hrs , t3 –12 hrs, t4 -24 hrs, t5 – 2 days |
|
|
Target Sample Size
|
Total Sample Size="57" Sample Size from India="57"
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)
|
31/08/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mandubrunosai231065@gmail.com].
- For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim of this study is to assess and compare the effect of one time versus two time Piezoperforation in orthodontic tooth movement during enmasse retraction in maxilla using piezotome To assess the orthodontic tooth movement using one time piezoperforation compared to control To assess the orthodontic tooth movement in Two time Piezoperforations compared to control. To compare the orthodontic tooth movement using one time versus two time piezoperforation compared to control. Procedure Participants of age 18-25 years with bimaxillary protrusion or Angle’s class II division 1 malocclusion with mild crowding 1-3 mm assessed by little’s irregularity index requiring extraction of upper 1st premolars will be selected from the outpatient department of Orthodontics. written informed consent will be taken. patients will be selected and randomly assigned into test and control sites by block randomisation . Levelling and alignment will be done. Premolars will be extracted and the trial starts after one month of extraction T0 and en-masse retraction of the anterior teeth will be initiated. The trial ends at the end of 3 months T4 Piezoperforations will be performed using piezotome , under local infiltration of 2ml Lignocaine . Three small perforations with each perforation of 1.5 mm diameter and 4 mm depth were done bilaterally in the extraction space distally to the canine.The perforations were spaced 3 mm apart vertically , which was measured using William’s periodontal probe clinically. Bleeding is controlled, and canine retraction will be started immediately on both sides using Nickel Titanium closed coil springs delivering 150 gm force. The second MOP will be performed only in the Group III experimental group 6 weeks after the first MOP. Group I -No intervention in the Control group Group II-One time intervention of Piezoperforation will be given one month after extraction of premolars Group III-Two time interventions of piezo perforations will be given. The first intervention will be given after 1 month of extraction of premolars, and the second intervention will be given at the end of the 6th week. Impressions will be taken using alginate, and models will be poured. Measurements will be made using digital callipers with a sharpened fine edge of accuracy to 0.01mm. Each of the study subject will be provided with a specifically designed visual analogue scale VAS diary and are requested to note the intensity of perceived pain using the terms 0 – no pain to 10- the highest pain on a 10cm visual analogue scale at various points of time such as t1-2 hrs after piezoperforation,t2-6 hrs , t3 –12 hrs, t4 -24 hrs,t5 – 2 days The amount of tooth retraction will be measured at the 2nd T1, 4th T2, 8th T3, and 12th T4 weeks when the patient is scheduled for routine check-up visits. The radiographs will be taken at T0, T2, T4 to evaluate the inclination of canines and molars. |