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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  
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 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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mandubrunosai231065@gmail.com].

  6. 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.

  7. 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.

 

 
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