| CTRI Number |
CTRI/2019/07/020403 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of surgical perforation of alveolar bone on rate of tooth movemnet |
|
Scientific Title of Study
|
Effects of micro-osteoperforation on rate of tooth movement: A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Stephy Thomas |
| Designation |
PG student |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Dept of orthodontics
MANGALABAG
cuttack
Cuttack
ORISSA
753007
India |
| Phone |
07683859459 |
| Fax |
|
| Email |
stephyt2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surya Kanta Das |
| Designation |
Professor and Head Of The Department |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Dept of orthodontics
MANGALABAG
cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Stephy Thomas |
| Designation |
PG student |
| Affiliation |
SCB Dental College and Hospital |
| Address |
Dept of orthodontics
MANGALABAG
cuttack
Cuttack
ORISSA
753007
India |
| Phone |
07683859459 |
| Fax |
|
| Email |
stephyt2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastucture os provided by S.C.B DENTAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA.All the materials required for this study is brought by myself |
|
|
Primary Sponsor
|
| Name |
Stephy Thomas |
| Address |
Dept of orthodontics
SCB Dental College and hospital,cuttack,Odisha |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| STEPHY THOMAS |
SCB DENTAL COLLEGE AND HOSPITAL |
DEPT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CUTTACK, ODISHA 753007
Cuttack
ORISSA |
07683859459
stephyt2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee ,SCB dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional retraction |
retraction using niti coil spring without micro-osteoperforation.timing of examination is same as that of intervention side |
| Intervention |
micro osteoperforation |
it is done with the help of physiodispenser and lance drill.it is the procedure for creating perforations in the alveolar bone with out elevating flap. Three perforation will be made mesial and distal side of canine tooth .it will be done once just before the start of retraction step. Changes in rate of tooth movement and periodontal status will be recorded for a period of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Class I bimaxillary protrusion or Class II div 1 malocclusion
2) Extraction of upper first premolar teeth as a part of treatment plan
3) Healthy periodontal status
4) Average Frankfort Mandibular Plane (FMA) angle |
|
| ExclusionCriteria |
| Details |
Patients on long term corticosteroid therapy or other medications that slowdown bone metabolism excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Micro-osteoperforation on periodontal structures along with the assessment of rate of tooth movement. |
3 months time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect o micro-osteoperforation on canine angulation, canine rotation, root resorption |
3 months time period |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
08/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
With increasing number of adult patients seeking orthodontic treatment, shorter treatment duration has become a common demand. Lengthier orthodontic treatment time poses several drawbacks such as increased predisposition to dental caries, gingival recession and root resorption. Though accurate and precise control of tooth movement can be optimized with the proper use of mechanics, however the rate of tooth movement depends on the reaction of the surrounding tissue to the orthodontic force. The micro-osteoperforation technique has the unique advantage of being flapless minimally invasive method for accelerating the tooth movement. As MOP is a recent development, further exploration of this technique is needed. |