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CTRI Number  CTRI/2025/08/092188 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Do sonic or oscillating tooth brushes speed up tooth movement during braces treatment?  
Scientific Title of Study   Comparison of the effect of sonic and oscillating tooth brushes on orthodontic tooth movement during en-masse retraction-A randomized clinical 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  BESTA VIJAYA LAKSHMI 
Designation  POST GRADUATE 
Affiliation  NARAYANA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS NARAYANA DENTAL COLLEGE AND HOSPITAL CHINTAREDDYPALEM 524003
NARAYANA DENTAL COLLEGE AND HOSPITAL CHINTAREDDYPALEM 524003
Nellore
ANDHRA PRADESH
518002
India 
Phone  6281572358  
Fax    
Email  besthavijaya2017@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SINGARAJI GOWRI SANKAR 
Designation  PROFESSOR 
Affiliation  NARAYANA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS NARAYANA DENTAL COLLEGE AND HOSPITAL CHINTAREDDYPALEM

Nellore
ANDHRA PRADESH
524003
India 
Phone  9440012443  
Fax    
Email  drgowrisankar@gmail.com  
 
Details of Contact Person
Public Query  
Name  PRASAD MANDAVA 
Designation  PROFESSOR AND HEAD 
Affiliation  NARAYANA DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS NARAYANA DENTAL COLLEGE AND HOSPITAL CHINTAREDDYPALEM

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 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Private hospital/clinic 
 
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 
BESTA VIJAYALAKSHMI  NARAYANA DENTAL COLLEGE AND HOSPITAL  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS NARAYANA DENTAL COLLEGE AND HOSPITAL CHINTAREDDYPALEM NELLORE 524003
Nellore
ANDHRA PRADESH 		 6281572358

besthavijaya2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL 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  OSCILLATING TOOTH BRUSH  Oscillating tooth brush having frequency of 60HZ 
Intervention  SONIC TOOTH BRUSH  SONIC TOOTH BRUSH 316HZ 
 
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 littles index
5.space requirement showing all four premolar extractions
6.No history of orthodontic treatment
7.Healthy teeth without any caries or active lesions
8.Patients with full permanent dentition
9.Patients without any habit of alcohol intake and smoking
 
 
ExclusionCriteria 
Details  1.Evidence of bone loss or periodontal problems
2.Patients with systemic diseases
3.Patients with pacemakers and any other medical devices that interfere with vibration
4.Patients taking medication that can interfere with orthodontic tooth movement
5.Extractions other than 1st premolar extraction in the upper arch
6.Crowding greater than 3mm
7.Pregnant patients
8.Patients with removable appliances
and additional appliances that could be unpredictable pain sources such as headgear and miniscrew
9.Patients who has undergone orthognathic surgery
10.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 
To measure the amount of tooth retraction  To measure the amount of tooth retraction at 4th,8th,12th,16th,20th and 24th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Intensity of perceived pain will be measured using visual aalogue scale  t1-2 hours after arch wire placement,t2-6hours,t3-at bed time,t4-24hours,t5-2days,t6-3days,t7-7days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   26/08/2025 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) - 

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    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   Aim of the study is to evaluate the effect of sonic and oscillating tooth brushes on orthodontic tooth movement during en-masse retraction. 
1. To evaluate the effect of sonic toothbrushes on orthodontic tooth movement during en-masse retraction compared to control group. 
2. To evaluate the effect of oscillating toothbrushes on orthodontic tooth movement during en-masse retraction compared to control group. 
3. To evaluate the effect of vibration on pain perception using sonic and oscillating tooth brushes compared to control group.
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. The trial starts after levelling and alignment(TO). Premolars will be extracted and en-masse retraction of the anterior teeth will be initiated. The trial ends at the end of 6 months. Group 1,subjects will be asked to apply vibrations using sonic toothbrush vibrating at 316Hz for 10 min immediately after arch wire placement and twice daily in the morning and night for 4 months. Group 2, Subjects will be asked to apply vibrations using oscillating toothbrush vibrating at 60 Hz for 10 min immediately after arch wire placement and twice daily in the morning and night for 4 months. Group 3 acts as control group. No intervention in the control group. Subjects in test groups will be reminded to use electric toothbrushes twice daily(20min/day) by sending an alarm using To Do Reminder mobile app. 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 participant will be provided with a specifically designed visual analogue scale (VAS) 52 diary (Appendix) 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 in the first 6 weeks at various points of time such as t1-2 hours after arch wire placement; 12-6 hours; t3 - at bed time; t4 -24 hours; t5 - 2 days; t6 - 3 days; t7 - 7 days. The amount of tooth retraction will be measured at 4th(T1),8 th(T2),12th(T3),16th(T4), 20th(T5),24th(T6) weeks when the patient is scheduled for routine check up visits. The radiographs are taken at T0 and T6 to evaluate the inclination of canines and molars. Data will be collected for intergroup and intragroup comparison by statistical analysis.
 
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