| CTRI Number |
CTRI/2017/10/010290 [Registered on: 31/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Osteo-perforations for faster Maxillary Canine retraction. |
|
Scientific Title of Study
|
Effects of Trans Mucosal Micro Osteo-perforations on the rate of Maxillary Canine retraction : A Split mouth Randomized clinical study |
| Trial Acronym |
EMOMCR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PGIDS/IEC/2015/68 dated- 19/05/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSACHIN PARASHAR |
| Designation |
Postgraduate |
| Affiliation |
University of Health Sciences Rohtak (UHSR) |
| Address |
Room no.201,
Department Of Orthodontics and Dentofacial Orthopaedics,
Post Graduate Institute of Dental Sciences, Rohtak
E-267,shastri nagar,delhi-110052
Rohtak
HARYANA
124001
India |
| Phone |
9654350577 |
| Fax |
|
| Email |
dr.sachinparashar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha sharma |
| Designation |
Head of the department |
| Affiliation |
University of health sciences (UHSR), rohtak |
| Address |
Room no.201,
Department of orthodontics and dentofacial orthopaedics,
PGIDS,
medical mor,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9999362277 |
| Fax |
|
| Email |
rajsringari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SACHIN PARASHAR |
| Designation |
Postgraduate |
| Affiliation |
University of Health Sciences Rohtak (UHSR) |
| Address |
Room no.201,
Department of Orthodontics and Dentofacial Orthopaedics,
Post Graduate Institute of Dental Sciences, Rohtak
E-267,shastri nagar
Rohtak
HARYANA
124001
India |
| Phone |
9654350577 |
| Fax |
|
| Email |
dr.sachinparashar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.SACHIN PARASHAR
Post Graduate, Deparment of Orthodontics
Post Graduate institute of Dental Sciences(PGIDS),rohtak.
|
| POST GRADUATE INSTITUTE OF DENTAL SCIENCES , ROHATK |
|
|
Primary Sponsor
|
| Name |
sachin parashar |
| Address |
E-267
shastri nagar
delhi-110052 |
| Type of Sponsor |
Other [sachin parashar] |
|
|
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 Rekha Sharma |
POST GRADUATE INSTITUTE OF DENTAL SCIENCES (PGIDS), Rohtak |
Department of Orthodontics and Dentofacial Orthopaedics,
Room number- 201
Post Graduate Institute of Dental Sciences(PGIDS)
Medical Rd, Rohtak, Haryana 124001
Rohtak
HARYANA |
9999362277
9999362277
rajsringari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,PGIDS,ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
class II division 1 malocclusion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL |
The opposite half of the patient served as control and did not receive any microperforations .
|
| Intervention |
transmucosal micro-osteo perforations |
The experimental side – This half received six MOPs, three MOPs mesial and three MOPs distal to canine(in a vertical line) by self-drilling micro screw implant (Tomas-Pin SD N 08, DENTAURUM GmbH & Co. KG) having length of 8mm and thread diameter of 1.6mm and made from titanium grade 5 according to the ASTM(American Society for Testing and Materials) with the help of micro implant srew driver (Tomas, DENTAURUM GmbH & Co. KG), before initiation of canine retraction after leveling and aligning of dental arch . Before the application of the MOPs, patients were asked to wash their mouth twice by chorhexidine for 1 minute. MOPs were performed on the buccal cortical bone only, under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) with standard asepsis, and no flap was raised.MOPs were done starting 2mm apical to the alveolar crest, with each perforation being 2mm apart. Mini implant depth guide were customized using syringe and self cure acrylic of 3mm and 5 mm to reach the 3 to 5 mm depth of MOPs for labial cortical perforation around the canine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with class II div.1 malocclusion requiring bilateral extraction of maxillary first premolars.
2. Overjet of less than 10mm.
3. No debilitating systemic disease.
4. No radiographic evidence of bone loss.
5. No history of periodontal disease/ therapy.
6. No smoking habit.
7. No gingivitis or untreated caries.
|
|
| ExclusionCriteria |
| Details |
1.overjet more than 10mm
2. Presence of any signs and symptoms of gingival and periodontal diseases.
3. History of Long-term medication
4. Systemic diseases.
5. Evidence of bone loss.
6. Smoking habit.
7. Any carious Lesions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The rate of canine movement was 66% or 1.66times and 32% or 1.3 times faster in experimental side during first four and eighth week respectively, as compared to the control side. |
The rate of canine movement was 66% or 1.66times and 32% or 1.3 times faster in experimental side during first four and eighth week respectively, as compared to the control side. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.There is minimal root resorption and marginal bone loss.
2.The difference in the level of pain, ease and satisfaction with the procedure seems insignificant between the MOP assisted and conventional orthodontics.
|
0,4,8,12,16th weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2015 |
| Date of Study Completion (India) |
11/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective: To evaluate the effect of Transmucosal Micro Osteo-perforations on the rate of canine retraction. metod:18 patients with the mean age of 20.4 + 1.8 years, who had a Class II Division 1 malocclusion and requires extraction of maxillary first premolars were selected and their maxillary halves were randomized in experimental and control group. Treatment was initiated by bonding 0.022†slot MBT straight wire appliance.Individual Canine retraction was done on 0.017â€Ã— 0.025†stainless steel arch wire. Transmucosal MOP were done on experimental side with 3 perforations mesial and 3 distal to canine. Active intervention for each side is done using 8mm dentaurum mini implant screw and driver. Impressions records were taken at 4th , 8th , and 12th & 16th weeks of canine retraction. CBCT was taken before initiation of retraction and post 12th week of canine retraction, for assessment of changes in the marginal bone height and apical root resorption. Results/findings: 1. There was significant difference in the rate of canine retraction between the Transmucosal Micro Osteo-Peroration assisted and standard orthodontic technique . 2. Transmucosal MOP shows rate of canine retraction 1.6 times faster or 66% higher in the first 4 weeks that tends to decrease after 8th week than the conventional technique. 3. There is minimal root resorption and marginal bone loss. 4. The difference in the level of pain, ease and satisfaction with the procedure seems insignificant between the MOP assisted and conventional orthodontics. |