| CTRI Number |
CTRI/2025/07/091477 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe the impact of Sonic toothbrush on the rate of orthodontic tooth movement: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Evaluation and Comparison of the effects Of SONIC toothbrush with Manual toothbrush on the rate of Enmasse retraction of anterior teeth in the patients undergoing fixed Orthodontic treatment: A Randomized 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 |
Dr Sneha Bhaisare |
| Designation |
PG student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9579719993 |
| Fax |
|
| Email |
snehabhaisare9993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Kumar |
| Designation |
Associate Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7798629818 |
| Fax |
|
| Email |
akankshakumar04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Bhaisare |
| Designation |
PG student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9579719993 |
| Fax |
|
| Email |
snehabhaisare9993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College Dental College And Hospital, Nagpur,India 441110 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Bhaisare |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College Dental College And Hospital, Wadhamna Road Wanadongri Hingna, Nagpur,India 441110 |
| 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 |
| Sneha Deepak Bhaisare |
swargiya dadasaheb kalmegh smruti dental hospital |
201,Department of Orthodontics and Dentofacial Orthopaedics
Nagpur
MAHARASHTRA |
9579719993
snehabhaisare9993@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual Toothbrush |
It is used in the study to compare the rate of Enmasse retraction of anterior teeth in the patients undergoing fixed Orthodontic treatment in comparison to the Sonic toothbrush. |
| Intervention |
Sonic Toothbrush |
It is used in the study to look for its effects on the rate of enmasse retraction of anterior teeth in the patients undergoing fixed orthodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18-30 years.
2. Patients with bimaxillary protrusion having minimal crowding or crowding less than 3mm and requiring 1st premolar extraction with absolute anchorage.
3. Patients with average growth pattern.
4. Systemically healthy patients.
5. Patients with healthy periodontium with generalized probing depth of 3 mm(Williams Probe) and no radiographic bone loss.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had taken NSAIDs or opioids within a month before the study.
2. Patients with poor oral hygiene (Gingival index scores less than 1) and periodontal disease were excluded from this study.
3. Patients with systemic illnesses, syndromes, oral lesions, bony disease or pathologies.
4. Patients with grade I,II,III mobility.
5. Patients with dental implants.
6. Patients with horizontal and vertical growth pattern.
7. Patients with hyperactive mentalis muscle.
8. Patients with oral habits.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effects of sonic toothbrush with manual toothbrush on the rate of en-masse retraction of anterior teeth for six months in the patients undergoing fixed orthodontic treatment. |
The rate of enmasse retraction will be assessed at 30days, 60days, 90days, 120days, 150days,180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2025 |
| 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 Yet Recruiting |
| 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
|
Introduction:- The average duration of orthodontic treatment with fixed appliances extends
from 18-24months, despite of having various advances and innovation in
orthodontic appliances and their design1. Accelerating the rate of
tooth movement can significantly reduce the duration of orthodontic treatment2.
There are several methods of accelerating tooth movement, such as: 1) Pharmacological-(corticosteroids, vitamin
D3, prostaglandins )3.
2) Surgical-(distraction osteogenesis,
piezocision, alveolar corticotomy) 4.
3) Physical or mechanical-(electric currents,
resonant vibration, low level laser therapy, photobiomodulation) 5.
However, pharmacological method has certain undesirable side effects and
surgical method being invasive causing discomfort to the patient3. High frequency
resonance vibration combined with orthodontic tooth movement results in release of inflammatory biomarkers like IL1 beta,
PGE2, TNF alpha leading to bone remodeling and periodontal tissue adaptability6.
A number of in vivo and in
vitro studies have suggested that high frequency vibration are noninvasive and
can affect the bone metabolism and increase rate of tooth movement7.
There are various commercially available devices like AcceleDentTM,
VPro5®, Orthopulse that have been tried to accelerate orthodontic tooth
movement. AcceleDent has used 30Hz of vibrational forces on to the human
subject for 20 minutes per day for six months similarly, there is another
commercial device, but with high-frequency mechanical vibration (HFMV), is the
VPro5® device at 120 Hz, 5 min per day8,9.
Leethanakul et al reported that
light orthodontic force along with electric toothbrush (Colgate Motion-Multi
Action) with rotating and vibratory head having frequency of 125 Hz enhanced
the release of biomarkers like interleukin 1 beta from the gingival crevicular
fluid and accelerated orthodontic tooth movement10.
There are different types of toothbrushes available in the market such as
manual, powered with oscillating head and sonic toothbrush11. In the
recent era, sonic toothbrush has been routinely used for maintaining oral
hygiene. Objectives: -To
evaluate and compare the effects of sonic toothbrush on the rate of en-masse
retraction of anterior teeth for six months in the patients undergoing fixed orthodontic
treatment. |