| CTRI Number |
CTRI/2022/01/039459 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the speed of alignment of lower front teeth using two different methods of accelerating tooth movement |
|
Scientific Title of Study
|
COMPARISON OF THE EFFECTIVENESS OF CONVENTIONAL AND LASER AIDED MICRO- OSTEOPERFORATIONS IN ACCELERATED ALLEVIATION OF LOWER INCISOR CROWDING-A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lichi Solanki |
| Designation |
Postgraduate student, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College And Hospital |
| Address |
Department of Orthodontics,Clinic 27, Fifth Floor,
no 162. Poonamallee High road,Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
09623388117 |
| Fax |
|
| Email |
lichisolanki90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SP Saravana Dinesh |
| Designation |
Professor, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College And Hospital |
| Address |
Department of Orthodontics,Clinic 27, Fifth Floor,
no 162. Poonamallee High road,Chennai
Department of Orthodontics,Clinic 27, Fifth Floor
no 162.Poonamallee High road,Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
09884115197 |
| Fax |
|
| Email |
drsaravanadinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lichi Solanki |
| Designation |
Postgraduate student, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College And Hospital |
| Address |
Department of Orthodontics,Clinic 27, Fifth Floor,
no 162. Poonamallee High road,Chennai
Department of Orthodontics,Clinic 27, Fifth Floor,
no 162. Poonamallee High road,Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
09623388117 |
| Fax |
|
| Email |
lichisolanki90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Denatl College and Hospital ,SIMATS |
|
|
Primary Sponsor
|
| Name |
Dr Lichi Solanki |
| Address |
Department of Orthodontics,Clinic 27, Fifth Floor,
no 162. Poonamallee High road,Chennai |
| 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 |
| Dr Lichi Solanki |
Saveetha Dental College and Hospital |
Clinic 27, Fifth floor, Department of Orthodontics and Dentofacial Orthopedics,
no 162. PH road, Vellapanchavadi ,Chennai
Thiruvallur
TAMIL NADU |
09623388117
lichisolanki90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers undergoing Orthodontic treatment |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group
|
Strap up with MBT Prescription ,round niti and active laceback.
-total duration- 7-8 months
|
| Intervention |
Lasercision in lower anterior interdental regions |
Strap up with MBT Prescription ,round niti and active laceback
At a distance 4mm cervical from the tip of interdental gingiva, multiple punctures with laser tip and the punctures being 1mm apart for upto 6 mm length vertically into the depth of cortical bone.
total duration- 6-7 months |
| Intervention |
Micro-osteoperforation in lower anterior interdental regions |
Strap up with MBT Prescription ,round niti and active laceback
MOP- clinically 4mm cervical from the tip of interdental
gingiva, there will be 4 punctures with a diameter of 1.8-2mm and the punctures being 2mm apart into the depth of the cortical bone.
total duration- 6-7 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 16- 35 years.
Patients with permanent teeth
Patients with moderate crowding of more than 4mm and according to Littles irregularity index
Therapeutic extraction of lower 1st premolars.
No radiographic evidence of bone loss
|
|
| ExclusionCriteria |
| Details |
Medically compromised patient.
Medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, drugs affecting bone metabolism , hyperparathyroidism, osteoporosis, uncontrolled diabetes)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of decrowding in lower anterior regions |
Rate of de-crowding assessed 3 weeks apart until end of decrowding.
Approx- 6-7 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone changes- cortical bone height and thickness, root resorption |
Assessed using pre- operative CBCT and CBCT at the end of decrowding.
Approx- 6-7 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
20/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not avaliable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this randomized control trial is to compare the effectiveness of micro-osteoperforation and Lasercision in acclerated alleviation of lower anterior crowding. There is a control group with no on intervention. Patients with age group of 16-35 years with lower anterior Crowding greater than 4mm (Little’s Irregulaity Index) are selected. Only patients requiring all 4 first premolar extractions are included in the study. All patients are strapped up with 0.022 slot MBT Prescription. Intervention is performed just prior to placing the arch wire in the lower arch. Under local infiltration , MOP and punch holes are placed in the respective groups. Control group only strap up with active lacebacks. Every three weeeks until decrowding is achieved, intraoral scans and photos are taken. Pretreatment and post treatment CBCT taken for evaluation of bone changes. Rate of decwding is assessed. |