| CTRI Number |
CTRI/2017/11/010610 [Registered on: 23/11/2017] Trial Registered Prospectively |
| Last Modified On: |
19/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of osteo-perforations for faster mandibular anterior decrowding. |
|
Scientific Title of Study
|
Effects of Transmucosal micro osteo-perforations on the rate of alleviating mandibular anterior crowding : A Randomized controlled 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 |
Mehak Bansal |
| Designation |
Post Graduate student |
| Affiliation |
Post Graduate Institute Of Dental Sciences, Rohtak |
| Address |
Room Number 202,Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak
S.C.F-16, Huda Complex, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9953902553 |
| Fax |
|
| Email |
mehakbansal420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha Sharma |
| Designation |
Senior Professor and Head |
| Affiliation |
Post Graduate Institute Of Dental Sciences, Rohtak |
| Address |
ROOM NO. 202, Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9467784352 |
| Fax |
|
| Email |
rajsringari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Davender Kumar |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute Of Dental Sciences, Rohtak |
| Address |
ROOM NO. 202, Department of Orthodontics and Dentofacial Orthopaedics, PGIDS , Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8950447738 |
| Fax |
|
| Email |
davenderkumar0195@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Mehak Bansal, Post Graduate student , Room NO. 202, Department of Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak |
| Intramural Research Grant, Pt. Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
|
|
Primary Sponsor
|
| Name |
Intramural Research Grant from University budget |
| Address |
Pt. Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mehak Bansal |
Room No. 202, Post Graduate student, Department of Orthodontics and Dentofacial Orthopaedics, Rohtak |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mehak Bansal |
Post Graduate Institute of Dental Sciences, Rohtak |
Room No. 202, Second Floor, Department of Orthodontics and Dentofacial Orthopaedics.
Rohtak
HARYANA |
9953902553
mehakbansal420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, PGIDS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dental malocclusion with lower anterior crowding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Orthodontic tooth movement without micro-osteoperforation |
This group will not receive Transmucosal micro-osteoperforation |
| Intervention |
Transmucosal Micro-Osteoperforation |
Patients who met inclusion criteria will be randomly assigned to control and experimental groups. Treatment will be iniated by bonding 0.022" slot MBT straight wire appliance. The main intervention in this clinical study is to perform six transmucosal micro-osteoperforations(MOPs), two MOPs each interproximally between mandibular canine and lateral incisor and between mandibular central incisors on labial aspect of mandible (in a vertical line ) with the help of self drilling implant, under local anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1-Mandibular anterior irregularity index upto 6 mm
2-Single arch or double arch treatment
3-Non extraction treatment in the mandibular arch
4-Presence of full complement dentition from first molar to first molar
5-No spaces in the mandibular arch
6-Patient with healthy periodontium and no attachment loss of greater than 2 mm
7-The amount of crowding should allow for bracket placement
8-No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances or Headgear prior to the complete alignment of mandibular anterior teeth |
|
| ExclusionCriteria |
| Details |
1- Failure to provide oral and written consent to participation
2-Medical problems that effect tooth movement
3-Presence of primary teeth in the mandibular anterior area
4-Missing permanent mandibular anterior teeth
5-Inability to place bracket in the mandibular anterior teeth
6-Breakage of any of the mandibular anterior brackets that have not been replaced within a week
7- Presence of any signs and symptoms of gingival and periodontal diseases
8-Evidence of bone loss |
|
|
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 |
| To evaluate the effect of transmucosal micro osteo-perforations on the rate of alignment of mandibular anterior teeth as compared to conventional orthodontics group. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To compare the time required to achieve alignment of crowded mandibular anterior teeth
2-To compare subject’s perception of pain, comfort and satisfaction using two
questionnaires.
3-To compare the marginal bone height and apical root resorption around mandibular
anterior teeth between the transmucosal micro osteo-perforations assisted and conventional
orthodontics through CBCT.
|
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2017 |
| Date of Study Completion (India) |
19/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title :Effects of Transmucosal
micro osteo-perforations on the rate of alleviating mandibular anterior crowding
: A Randomized controlled clinical study
Rationale: The ability to
accelerate the tooth movements would be advantageous for orthodontists because
treatment duration has been linked to an increased risk of gingival
inflammation, decalcification, dental caries and especially root resorption.Of
the various methods used for accelerating orthodontic tooth movement, surgical
approaches (alveolar decortications or corticotomies) has shown the most
promising and consistent results but are associated with postsurgical
morbidity(swelling, pain). Micro-osteoperforation is a minimally invasive
technique which is an effective, comfortable, and safe procedure to accelerate
tooth movement.
Ø Aims
and Objectives
: To evaluate the effect of transmucosal micro-osteoperforations
on the rate of alignment of mandibular anterior teeth as compared to conventional orthodontic group.
Also
to compare the time required to achieve
alignment, subject’s perception of pain, comfort , satisfaction, marginal bone
height and apical root resorption around mandibular anterior teeth between the
two procedures.
Setting: Department of
Orthodontics and Dentofacial Orthopaedics, PGIDS, Rohtak.
Study Design: Randomized controlled
clinical trial
Time frame: 08-12 months
Population/participant : Inclusion criteria:- Moderate crowding
cases,15-25 yrs of age,single or double arch, non-extraction treatment in the
mandibular arch,no spaces in the mandibular arch and healthy
periodontium .Exclusion Criteria:-Failure
to provide oral and written consent to participation,medical problems that
affect tooth movement,presence of primary teeth in the mandibular anterior
area,missing permanent mandibular anterior teeth,presence of any signs and
symptoms of gingival and periodontal diseases,evidence of bone loss.
Sample size – a sample size of 28 patients
with fourteen patients in each group.
Methods- Patients who met the
inclusion criteria will be randomly assigned to the control and experimental
groups. Treatment will be initiated by bonding 0.022†slot MBT
straight wire appliance. The main intervention in this clinical study is to
perform six transmucosal micro-osteoperforations(MOPs), two MOPs each
interproximally between mandibular canine and lateral incisor and between
central incisors on labial aspect of mandible(in a vertical line).
Outcome Measures– The primary outcome variables will be to compare rate of alignment of crowded mandibular anterior teeth (canine to canine). Secondary
will be
Ø
To compare time
required to achieve alignment.
Ø
To compare subject’s perception of
pain,comfort and satisfaction using questionnaires
Ø
To compare the marginal bone height and
apical root resorption through CBCT.
Statistical
Analysis
:Data will be checked for normality. If normally distributed then student t
test will be applied for non related variables and paired t test will be for
related variables. If not normally distributed then mann- whitney test will be
applied for non related variables and wilcoxon signed rank test for related
variables. Categorical data will be
analyzed using chi-square test and wilcoxon signed rank test. |