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CTRI Number  CTRI/2025/03/082624 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Orthodontic Tooth Movement Following Small Controlled Perforations in the bone Combined with the Use of Electric Toothbrush – A Comparative Study. 
Scientific Title of Study   Evaluation of Orthodontic Tooth Movement Following Micro- osteoperforation Combined with the Use of Electric Toothbrush – A Comparative 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 Astha Rajbhandari  
Designation  Post graduate (Department of Orthodontics and dentofacial orthopedics) 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and dentofacial orthopedics A B Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7318293795  
Fax    
Email  astha.24dort06@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr MS Ravi 
Designation  Professor, Head of Department, Vice Principal 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and Dentofacial Orthopedics AB Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845221386  
Fax    
Email  drmsravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MS Ravi 
Designation  Professor, Head of Department, Vice Principal 
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Department of Orthodontics and Dentofacial Orthopedics AB Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845221386  
Fax    
Email  drmsravi@gmail.com  
 
Source of Monetary or Material Support  
A B Shetty Memorial Institute Of Dental Sciences, Deralakatte, Mangalore Pincode : 575018 India 
 
Primary Sponsor  
Name  Dr Astha Rajbhandari  
Address  Department of Orthodontics and Dentofacial Orthopedics AB Shetty Memorial Institute Of Dental Sciences, Deralakatte, Mangalore Pin code: 575018 India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Professor Dr MS Ravi  AB Shetty Memorial Institute of Dental Sciences Deralakatte Mangalore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Astha Rajbhandari  A B Shetty Memorial Institute Of Dental Sciences  Department of Orthodontics and Dentofacial Orthopedics
Dakshina Kannada
KARNATAKA 
7318293795

astha.24dort06@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES INSTITUTIONAL ETHICAL COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Malocclusion 
Patients  (1) ICD-10 Condition: K00||Disorders of tooth development anderuption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional orthodontic treatment  Following fixed orthodontic treatment protocol to teat malocclusion 
Intervention  Micro osteoperforation and use of electric toothbrush  Micro-osteoperforation will be created distal to canine (spaced 1-3mm apart) at both buccal and palatal aspects in the extraction space, as close as possible to the roots of canine. It will be performed after the induction of local anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Patients who need orthodontic treatment with requiring therapeutic extraction of bilateral maxillary first premolar followed by canine retraction
Healthy systemic condition
No previous Orthodontic/Surgical treatment
Good oral hygiene
Gingival probing depth of less than 3mm 
 
ExclusionCriteria 
Details  Medically compromised patients
Patient taking drugs modifying normal bone physiology
Patients with congenital and craniofacial syndromes
Bone pathology and soft tissue lesions of the palate/gingiva
Non-compliant patients/ not willing to take part in the study
Poor oral hygiene
Patients with congenital tooth deficiency
Cortical bone fracture during extraction of premolar 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The combined procedure of micro-osteoperforation and the use of electric toothbrush results in a
significantly increased rate of orthodontic tooth movement with minimal adverse dentoalveolar effects compared to that of the conventional methods. 
T0= Before start of canine retraction
T1= 45 days after the onset of canine retraction
T2= 90 days after the onset of retraction or at the completion of canine
retraction, whichever is earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased duration of overall orthodontic treatment  24 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   10/04/2025 
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="2"
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  

NEED FOR STUDY

Orthodontic treatment often involves prolonged durations, which can cause discomfort and reduce patient compliance. Various techniques have been explored to accelerate tooth movement without compromising treatment outcomes, such as mechanical vibrations and surgical interventions, along with minimal adverse effects. Recent studies suggest that vibrational devices may influence bone remodeling, promoting faster orthodontic tooth movement.2 Additionally, minimally invasive techniques like micro- osteoperforation can enhance the biological response, facilitating accelerated tooth movement. This study investigates the combined effect of micro-osteoperforation and use of the electric toothbrush on the rate of orthodontic tooth movement and associated tissue changes, aiming to evaluate their synergistic potential to optimize orthodontic treatmentsTo evaluate the effect of micro-osteoperforation combined with electric toothbrush on the rate of orthodontic tooth movement and associated dentoalveolar changes. 


CLINICAL SIGNIFICANCE

Prolonged orthodontic treatment is associated with adverse effects such as root resorption, periodontal issues, decalcification, and temporomandibular dysfunction. Therefore, reducing treatment duration is of critical importance to both clinicians and patients.

By intentionally creating controlled, reversible bone injury, osteoclastic activity is stimulated, shifting bone metabolism into a more catabolic state. This phenomenon, known as the Regional Acceleratory

Phenomenon (RAP), forms the foundation for various accelerated orthodontic tooth movement techniques.

Assessing and comparing minimally invasive surgical approaches like Micro-osteoperforation with non-invasive techniques like vibrational frequency evaluated by electric toothbrush offers valuable insights into effective methods for speeding up orthodontic treatment while minimizing risks.


AIM: To evaluate the effect of micro-osteoperforation combined with electric toothbrush on the rate of orthodontic tooth movement and associated dentoalveolar changes.


OBJECTIVES:

To determine and compare the rate of orthodontic tooth movement (canine retraction) under following conditions:

a. following micro-osteoperforation

b. with the application of electric toothbrush

c. combined effect of both methods

To measure and compare gingival and periodontal status (gingival index/ pocket formation or bone loss/ mobility) between the groups.

To measure and compare root resorption, vertical alveolar bone changes, and horizontal bone thickness at mid-root and root apex levels of the maxillary canine region pre- and post-retraction with the help of radiographs between groups.


The study will be conducted on 34 patients reporting for Orthodontic treatment at the Department of Orthodontics and Dentofacial Orthopedics at AB Shetty Memorial Institute of Dental Sciences, Mangalore.

The patients requiring extraction of maxillary first premolar on both sides of the arch will be selected.


It is a split mouth study where the participants will be randomly divided into two groups:

a) Group A: Conventional orthodontic treatment with bilateral micro-osteoperforation.

Participants will use an electric toothbrush on one randomly allocated side.

b) Group B: Conventional orthodontic treatment only. Participants will use an electric toothbrush on one randomly allocated side.

The split mouth design is employed to minimize biological variability.

Patients will be allocated to different groups using the simple randomization method to ensure an unbiased and equal distribution.

Patients will be asked to extract the premolars prior to start of orthodontic treatment.

Banding and bonding of both upper and lower arch will be done as per the standard method.

After initial alignment, the maxillary canine retraction will be carried out by NiTi closed coil springs at the stage of 0.017x0.025 stainless steel maxillary arch wire.

A force of 150gm per side will be given and will be measured using a Dontrix gauge.

Absolute anchorage using mini-implants will be used for retraction.

Participants in Group A will undergo Micro-osteoperforation procedure bilaterally using commercially available orthodontic mini-implant screws with a diameter of 1.2mm and length of 8mm. It will be inserted to a depth of 6mm (measured from the soft tissue) using

a hand driver.

3 MOPs will be created distal to canine (spaced 1-3mm apart) at both buccal and palatal aspects in the extraction space, as close as possible to the roots of canine. It will be performed after the induction of local anesthesia.

All participants will receive a standardized 150 Hz electric toothbrush, ensuring uniform specifications and sourced from the same manufacturer. They will be instructed to hold the toothbrush against the mesio-labial surface of the experimental canine to apply

mechanical vibrations for at least 5 minutes, three times a day (at an interval of 6-8 hours between each use), for the duration of the study.

2 They will be advised to follow their regular cleaning routine for the rest of their teeth. A daily usage checklist will be provided, and participants will be asked to submit it during their monthly visits.


To record the rate of canine retraction, digital impressions will be made at specific time intervals.

T0= Before start of canine retraction

T1= 45 days after the onset of canine retraction

T2= 90 days after the onset of retraction or at the completion of canine retraction, whichever is earlier.


For measurements, following reference lines will be established:

a. Midpalatine raphe (MPR): formed from two points: one on the distal aspect of incisive papilla and the other at the posterior border of the raphe near fovea centralis

b. Rugae line (RL): formed by projection from the most medial point on the third palatal rugae.


Then the following measurements will be recorded digitally:

1. The distance between the cusp tip of the canine and the rugae line (DC) will be used to measure the anteroposterior canine movement.

2. The distance between the mesial contact point of the first permanent molar and the rugae line (DM) will be used to measure molar movement that is the anchorage loss.

3. The angle between the median raphe and the line through the mesial and distal edges of the canine (A) will be used to measure canine rotation.


The rate of retraction is determined by dividing distance moved in mm with time.


Gingival and periodontal health will be measured on both sides using a periodontal probe, pre and post retraction

-Gingival health: Gingival Index by Loe and Silness (1963)

Clinical attachment loss: WHO probe

Mobility: Millers Mobility Index


Root resorption, along with vertical and horizontal bone thickness at the mid root and root apex levels of maxillary canine region, will be evaluated on both sides using CBCT imaging before and after the retraction phase.

Data will be compared and analyzed using statistical analysis.

 
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