| 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
|
|
|
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
|
|
|
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 Studyâ€
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:
- To assess the traction duration and compare the
traction duration in traditional traction group(TT) & micro
osteoperforation assisted traction group(MAT)
- 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
- Patients aged 15-30 years
- 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 |