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CTRI Number  CTRI/2024/03/064039 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 12/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation Of The Micro-Osteoperforations And Piezocision On The Rate Of Canine movement. 
Scientific Title of Study   Comparative Evaluation Of The Micro-Osteoperforations And Piezocision On The Rate Of Canine Retraction: A Split Mouth 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 Gaikwad Darshan  
Designation  PG Student 
Affiliation  Surendera Dental college and research institute 
Address  Department of orthodontics and dentofacial orthopaedics A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Department of orthodontics and dentofacial orthopaedics A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Ganganagar
RAJASTHAN
335001
India 
Phone  7741957287  
Fax    
Email  darshang911@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Eenal Bhambri 
Designation  Prof and Head 
Affiliation  Surendera Dental college and research institute 
Address  Department of orthodontics and dentofacial orthopaedics, A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Department of orthodontics and dentofacial orthopaedics, A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Ganganagar
RAJASTHAN
335001
India 
Phone  7741957287  
Fax    
Email  dreenal700@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gaikwad Darshan  
Designation  PG Student 
Affiliation  Surendera Dental college and research institute 
Address  Department of orthodontics and dentofacial orthopaedics, A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Department of orthodontics and dentofacial orthopaedics, A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Ganganagar
RAJASTHAN
335001
India 
Phone  7741957287  
Fax    
Email  darshang911@gmail.com  
 
Source of Monetary or Material Support  
department of Orthodontics and dentofacial orthopedics of surendera dental college and research institute 
 
Primary Sponsor  
Name  Dr Gaikwad Darshan 
Address  Surendra Dental College And Research Institute HH gardens, power house road Sri ganganagar rajasthan 335001 
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 Gaikwad Darshan  Surendera dental college and research institute   Department of orthodontics and dentofacial orthopaedics, A block, Room No.3 surendera dental college and research institute, HH gardens, power house road, sri ganganagar rajasthan 335001
Ganganagar
RAJASTHAN 
7741957287

darshang911@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Surendera Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patient opting orthodontic treatment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  micro osteoperforations and peizocision  After disinfecting the area with betadine, the MOPs will be performed under local anesthesia using the TAD.MOPs will be created directly through the alveolar mucosa in the middle of the extraction space in the vertical direction . piezocision will involve gingival micro-incisions and vertical cortical cuts without flap reflection The Ultrasonic instrument will be adjusted to deliver a low frequency ultrasonic waves and used to perform corticotomy, the cortical alveolar incisions will be created inter proximally to a depth of 3mm.The surgical site will be rinsed with normal saline.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  •Full Permanent dentition.
•Well aligned arches.
•Maximum anchorage.
•Patients with Angles class I malocclusion with bimaxillary protrusion and Angles class II division 1 malocclusion requiring bilateral extraction of first Premolar.
•Good oral hygiene and periodontal Condition.
 
 
ExclusionCriteria 
Details  Medically compromised patients.
Chronic use of medications of i.e anti-inflammatory drugs, antibiotics, affecting OTM.
Poor oral hygiene.
Evidence of bone loss.
History of orthodontic treatment.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the amount of canine movement on MOP and Piezocision side  Baseline and at six months  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the amount of molar movement on MOP & Piezocision side
To evaluate the rotation & tipping of the canine & molar on MOP & Piezocision side
To evaluate the root resorption of canine 
Baseline & at six months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   23/03/2024 
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="2"
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  

AIM:Evaluate and compare the effect of micro-osteoperforation (MOP) and piezocision on the rate of orthodontic tooth movement in canine retraction.

OBJECTIVES:

1)     To evaluate the amount of canine movement on MOP side.

2)     To evaluate the amount of canine movement on piezocision side.

3)     To evaluate the amount of molar movement on MOP side.

4)      To evaluate the amount of molar movement on piezocision side.

5)      To evaluate the rotation and tipping of the canine on MOP side.

6)     To evaluate the rotation and tipping of the canine on piezocision side.

7)      To evaluate the rotation and tipping of the molar on MOP side  

8)      To evaluate the rotation and tipping of the molar on piezocision side.

9)     To evaluate the root resorption of canine if any on the MOP side and piezocision side.

10)    To find out the best method for controlled canine movement.  

 Materials:

In this study, following armamentarium will be required

1)     Mini-implant

2)     Piezotome Solo (Woodpecker, BS1 Insert)

3)     CBCT (Vatech A9)

4)     Alginate impression

5)     Transpalatal arch (TPA)

METHODOLOGY:

Pre-retraction (T0) alginate impression and Cone beam computed tomography scan (T0) will be taken for all subjects. All the selected subjects will require bilateral extraction of premolars.

      Orthodontic treatment protocol for all the patients will be bonded with metal MBT(Leone) prescription of 0.022- 0.028 inch and trans bond XT. All the indicated first premolars will be extracted and alignment and levelling will be performed using 0.014-0.016 NiTi arch wires. This will progress to 0.016-0.022 stainless steel wires and single canine retraction will be performed using sliding mechanics

.

MOP and Piezocision will be randomly allocated to the patients to choose the side of the procedure. Piezocision will involve gingival micro-incisions and vertical cortical cuts without flap reflection on randomly selected side. The Ultrasonic instrument (BS1 insert Piezotome) will be adjusted to deliver a low frequency ultrasonic waves (28-36 kHz) and used to perform corticotomy, the cortical alveolar incisions will be created inter proximally to a depth of 3mm. The 2 millimeters of marginal crestal bone will be held intact and the vertical groove will be extended along the entire length of canine root. The surgical site will be rinsed with normal saline.

On the other side of extraction, three MOPs will be performed. After disinfecting the area with betadine, the MOPs will be performed under local anesthesia using the TAD (1.8×8 mm).  The TAD will be screwed slowly into the alveolar bone, perpendicular to the bone surface till slight blanching of the surrounding soft tissue will be obtained to ensure full length penetration of the TAD, then the TAD will be unscrewed and removed.

MOPs will be created directly through the alveolar mucosa in the middle of the extraction space in the vertical direction and 3 mm apart. The first MOP will be located 5 mm away from the free gingival margin.

Canine retraction will be then commenced using NiTi closing coil springs applying 150 g extended between the first molar and canine hooks.

Follow-up visits will be scheduled every 3 weeks for re-calibrating the springs, and detecting any occlusal interferences that may arise during canine retraction. An upper alginate impression will be taken every visits. The study time will be continued till the completion of canine retraction, after which the final upper impression will be taken, and the patient will be referred to acquire the post-retraction CBCT (T1) image.

Evaluation of movements and rotation of canines and molar on both the sides, ie., MOP and piezocision side will be done both on the study model and by CBCT scan. The amount of canine movement will be measured in CBCT from the distal point of the lateral incisor to the mesial point of the canine that will be retracted.

For, amount of molar movement, incisive foramen will be marked, and a perpendicular to incisive foramen will be constructed in the transverse axis. The mesiobuccal cusp tip will be marked and a line will be constructed from the same to the true sagittal plane. Distance between the two transverse lines will be measured in pre and post retraction CBCT images.

The upper first molar and canine rotation will be measured as the angle between the molar horizontal axis and frontal plane in the axial view.

The long axis of the canine and molar will be marked, and angle will be formed with the true horizontal plane. The internal angle will be measured in pre and post retraction casesRoot resorption will be assessed using the multiplanar view of the EZ 3D software. The CBCT image will be adjusted using the re-orientation tool, such that the sagittal and the coronal cuts are parallel to the canine long axis. The two cross-sections showing the maximum canine root length will be selected for assessment using Malmgren index. Each canine will be given two scores (0–4) according to the root resorption severity detected from the labio-lingual and mesio-distal cross sections respectively. The difference between the pre and post-retraction scores for each canine will be calculated and evaluated statistically



 
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