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CTRI Number  CTRI/2025/03/081824 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Micro-osteoperforation to Accelerate Traction of Impacted Canine 
Scientific Title of Study   Accelerating Orthodontic Treatment with Micro-osteoperforation Assisted Traction of Maxillary Impacted Canine: In-vivo Study 
Trial Acronym  MOP Canine 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shafna V 
Designation  PG Resident 
Affiliation  PG resident, dept of orthodontcs 
Address  Room no:11, department of orthodontics, Govt. college of Dentistry, Indore

Indore
MADHYA PRADESH
452001
India 
Phone  8075033864  
Fax    
Email  shafnaabid5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ram Kishore Ratre 
Designation  Professor 
Affiliation  Government college of dentistry, Indore 
Address  Indore Madhya Pradesh

Indore
MADHYA PRADESH
452001
India 
Phone  9425070696  
Fax    
Email  rkratre@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ram Kishore Ratre 
Designation  Professor 
Affiliation  Government college of dentistry, Indore 
Address  Indore Madhya Pradesh


MADHYA PRADESH
452001
India 
Phone  9425070696  
Fax    
Email  rkratre@yahoo.co.in  
 
Source of Monetary or Material Support  
Government College O Dentistry, Indore 
 
Primary Sponsor  
Name  Dr Ram Kishore Ratre 
Address  Professor,Department of Orthodontics, Govt. College of dentistry, Indore 
Type of Sponsor  Other [] 
 
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 Shafna V  Government College of Dentistry, Indore  Room no:11, Department of orthodontics, Government college of dentistry,Indore, Madhya Pradesh
Indore
MADHYA PRADESH 
8075033864

shafnaabid5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Govt. College of Dentistry, Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micro-osteoperforation during exposure of impacted canine  The aligning and leveling of the maxillary dental arch will be performed using the fixed orthodontic appliance and will create sufficient space for aligning the impacted canine within the dental arch. In both study groups, the impacted canines will be surgically exposed using the closed flap approaches. MOPs will be performed under local anesthesia using IDO device for micro osteoperforation with FavAnchor straight hand driver. 2 MOPs will be placed where the impacted canine would be moved towards as well as, 2 each in mesial and distal sides of the canine crown . Each perforation will be 1.2 mm wide ,3 mm deep and 2mm apart from each other. An attachment with ligature wire will be bonded to the exposed canine crown . Follow-up orthodontic procedures: The traction force will be applied by tieing the ligature wire to the arch wire .The intensity of the applied traction force will be 60g measured using intraoral force guage. Re-activation will be done every 2 weeks until the appearance of half of the clinical crown of the impacted canine, this moment will be considered as the end of the active traction phase  
Comparator Agent  Traditional traction group  The aligning and leveling of the maxillary dental arch will be performed using the fixed orthodontic appliance and will create sufficient space for aligning the impacted canine within the dental arch. In both study groups, the impacted canines will be surgically exposed using the closed flap approaches. Follow-up orthodontic procedures: The traction force will be applied by tieing the ligature wire to the arch wire .The intensity of the applied traction force will be 60g measured using intraoral force guage. Re-activation will be done every 2 weeks until the appearance of half of the clinical crown of the impacted canine, this moment will be considered as the end of the active traction phase 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Maxillary impacted canines with less than 45-degree angle between the canine’s longitudinal axis and the vertical facial plane. 
 
ExclusionCriteria 
Details  1. More than 45-degree angle between the canine’s longitudinal axis and the vertical facial plane
2. Presence of contact between the canine crown and the lateral incisor root
3. Previous orthodontic treatment
4. Any medical condition that prevents oral surgery
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1-traction duration
 
After the eruption of half of canine crown into the oral cavity 
 
Secondary Outcome  
Outcome  TimePoints 
Velocity of traction movement  After the eruption of half of canine crown into the oral cavity 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/03/2025 
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 - NO
Brief Summary  

NAME OF THE DEPARTMENT: ORTHODONTICS & DENTOFACIAL ORTHOPEDICS

TITLE OF STUDY: “Accelerating Orthodontic Treatment with Micro-osteoperforation Assisted Traction of Maxillary Impacted Canine: In-vivo Study”

INVESTIGATOR: Dr SHAFNA V

CO-INVESTIGATOR: DR RAM K RATRE

INTRODUCTION- Micro-osteoperforation involves the creation of tiny perforations in the cortical bone surrounding the impacted tooth, utilizing minimally invasive procedures. These perforations stimulate localized bone remodeling, facilitating the movement of the impacted canine towards its desired position

AIMS :

To evaluate and compare the effectiveness of accelerating orthodontic treatment with micro osteoperforation- assisted traction of maxillary impacted canines with traditional method

OBJECTIVES:

  1. To assess the traction duration and compare the traction duration in traditional traction group(TT) & micro osteoperforation assisted traction group(MAT)
  2. To assess the velocity of traction movement, determined by divding the depth of impaction,which is defined as the distance from the impacted canine cusp tip to the occlusal plane,by the traction duration

METHODOLOGY

SAMPLE SIZE:30 patients,  GROUP I-Traditional traction group(TT)-15 patients

                        GROUP II- micro osteoperforation assisted traction group(MAT)- 15 patients

INCLUSION CRITERIA

  1. Patients aged 15-30 years
  2. Maxillary impacted canines with less than 45-degree angle between the canine’s longitudinal axis and the vertical facial plane.

EXCLUSION CRITERIA

1. More than 45-degree angle between the canine’s longitudinal axis and the vertical facial plane

2. Presence of contact between the canine crown and the lateral incisor root

3. Previous orthodontic treatment

4. Any medical condition that prevents oral surgery

PROCEDURE: 30 patients will be selected randomly and then will be divided into two groups. 15 patients will be assigned to conventional treatment group and 15 will be assigned to micro osteoperforation assisted traction  group.

The aligning and leveling of the maxillary dental arch will be performed using the fixed orthodontic appliance and will create sufficient space for aligning the impacted canine within the dental arch. In both study groups, the impacted canines will be surgically exposed using the closed flap approaches.

 MOPs will be performed under local anesthesia using IDO device for micro osteoperforation with FavAnchor straight hand driver. 2 MOPs will be placed where the impacted canine would be moved towards as well as, 2  each in mesial and distal sides of the canine crown . Each perforation will be 1.2 mm wide ,3 mm deep and 2mm apart from each other. An attachment with ligature wire will be bonded to the exposed canine crown .

Follow-up orthodontic procedures: The traction force will be applied by tieing the ligature wire to the arch wire .The intensity of the applied traction force will be 60g measured using intraoral force guage.  Re-activation will be done every 2 weeks until the appearance of half of the clinical crown of the impacted canine, this moment will be considered as the end of the active traction phase

STATISTICAL ANALYSIS: Statistical analysis will be done using an independent sample‘t’ test between-group comparison and within the group using paired‘t’ tests.

PATIENT INFORMATION LEAFLET & PATIENT CONSENT FORM-required

FACILITIES AVAILED FROM INSTITUTION: patients

FACILITIES AVAILED FROM OUTSIDE THE INSTITUTION: None

 
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