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CTRI Number  CTRI/2022/07/044421 [Registered on: 28/07/2022] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of micro bone perforation on upper canine retraction during orthodontic tooth movement 
Scientific Title of Study   Effect of micro-osteoperforation on maxillary canine retraction using sliding mechanics -an invivo study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavya M P 
Designation  Post graduate Resident 
Affiliation  Sree Anjaneya Institute Of Dental Sciences 
Address  Department of Orthodontics and Dentofacial Orthopaedics. Sree Anjaneya Institute of Dental Sciences Modakkallur kozhikode

Kozhikode
KERALA
673315
India 
Phone  9497248129  
Fax    
Email  drkavyamp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tojan Chacko 
Designation  Professor and Head 
Affiliation  Sree Anjaneya Institute Of Dental Sciences 
Address  Department of Orthodontics and Dentofacial Orthopaedics. Sree Anjaneya Institute of Dental Sciences Modakkallur kozhikode

Kozhikode
KERALA
673315
India 
Phone  9446441166  
Fax    
Email  tojanchacko@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tojan Chacko 
Designation  Professor and Head 
Affiliation  Sree Anjaneya Institute Of Dental Sciences 
Address  Department of Orthodontics and Dentofacial Orthopaedics. Sree Anjaneya Institute of Dental Sciences Modakkallur kozhikode

Kozhikode
KERALA
673315
India 
Phone  9446441166  
Fax    
Email  tojanchacko@gmail.com  
 
Source of Monetary or Material Support  
Sree Anjaneya Institute Of Dental Sciences. Modakkallur kozhikode kerala -673315 
 
Primary Sponsor  
Name  Dr Kavya M P 
Address  Department of Orthodontics and Dentofacial Orthopaedics Sree Anjaneya Institute Of Dental Sciences. Modakkallur kozhikode kerala - 673315 
Type of Sponsor  Other [SELF] 
 
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 Kavya M P  Sree Anjaneya Institute of Dental Sciences  5th Floor, PG Section, Department of Orthodontics and Dentofacial Orthopaedics
Kozhikode
KERALA 		 9497248129

drkavyamp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee, Sree Anjaneya Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M263||Anomalies of tooth position of fully erupted tooth or teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rate of orthodontic tooth movement with Micro-osteoperforation.  Rate of orthodontic tooth movement with Micro-osteoperforation along with fixed orthodontic mechanotherapy. Duration - 1 year and 6 months. 
Comparator Agent  Rate of orthodontic tooth movement without Micro-osteoperforation.  Rate of orthodontic tooth movement without Micro-osteoperforation alone with fixed orthodontic mechanotherapy . 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1)Angle’s Class 1 malocclusion with bidental proclination and class II malocclusion requiring maximum anchorage retraction.2)Subjects require extraction of first premolars as part of orthodontic treatment.3)No systemic disease.4)No radiographic evidence of bone loss.5)No history of periodontal therapy.6)No current active periodontal disease or carious lesions.7)Subject with healthy gingiva, having probing depth less than 4mm in all teeth. 8)Subject with gingival index and plaque index less than or equal to 1 Minimal crowding(< 4mm).9)No habit of smoking.10)Good Oral hygiene.11)Adequate alveolar bone trough width. 
 
ExclusionCriteria 
Details  1)Subject with age less than 15 years and greater than 35 years of age.
2)Subject who does not require therapeutic first premolar extraction.
3)Subject with poorly aligned, levelled arches.
4)Active periodontal disease or caries.
5)Gingival probing depth more than 4mm in teeth.
6)Poor oral hygiene.
7)Parafunctional habits.
8)Systemic disease or conditions or long-term use of medications
9)Subjects with habit of smoking.
10)Evidence of bone loss.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect on rate of orthodontic tooth movement with micro-osteoperforation and without micro-osteoperforation   0,2,4,6,8,10,12,14 and 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on clinical probing depth  0,16 weeks 
Effect on level of gingival margin  0,16 weeks. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) 02/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is split mouth randomized control trail without blinding, comparing the effect of micro- osteoperforation(MOP) on maxillary canine retraction using sliding mechanics on alternative right and left side of maxillary arch. 

STUDY HYPOTHYSIS

NULL HYPOTHESIS -The procedure of MOPs with IDO tip having dimension of 1.2mm×6mm does not accelerate the orthodontic tooth movement rate compared to conventional orthodontic treatment.

ALTERNATIVE HYPOTHESIS -The procedure of MOPs with IDO tip having dimension of 1.2mm×6mm will accelerate the orthodontic tooth movement rate compared to conventional orthodontic treatment.

The aim of this study is to compare the overall time taken to retract maxillary canine with and without MOP using sliding mechanics.

The objective is to  evaluate and compare effectiveness of trans-gingival MOP using an IDO device having a tip dimension of 1.2mm×6mm on buccal and palatal alveolar bone over extracted first premolar site by Split Mouth Technique.and also to evaluate and compare the effect of trans-gingival micro-osteoperforation on the clinical probing depth and level of gingival margin.

PROCEDURE - MOP is performed using IDO tip having a dimension of 1.2mm×6mm on buccal and palatal bone site of extracted first premolar. Three perforations per site at equal spacing of 3mm on buccal alveolar bone over extracted first premolar site and only two perforations on palatal alveolar bone at equal spacing of 3mm below the extracted first premolar site as there is approximation of anatomical structures. It is performed alternatively on left and right side of maxillary arch. Mini-implant is placed on interradicular space between  2nd premolar and 1st maxillary molar to prevent anchor loss by unwanted tooth movement of the posterior teeth during individual canine retraction. The force of retraction will be standardized using dontrix gauge. 

Clinical probing depth and gingival margin level were measured using UNC 15 probe from a fixed reference point.


 
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