| CTRI Number |
CTRI/2024/10/074573 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to evaluate the efficacy of the two methods with Miniscrew and without Miniscrew on upper front teeth in patients with improper bite |
|
Scientific Title of Study
|
Comparative evaluation of rate of Maxillary incisors intrusion between Mini screw and Burstone intrusion arch with helix in Deep bite patients-A Randomized Controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavithra P |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital,Cuddalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital,Cuddalore erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
7010495421 |
| Fax |
|
| Email |
pavinandhi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital,Cuddalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Government Dental College and Hospital,Cuddalore erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital,Cuddalore |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Government Dental College and Hospital,Cuddalore erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital, Cuddalore Erstwhile Rajah Muthiah Dental College and Hospital, Chidambaram,Cuddalore District,TamilNadu - 608002 (For Infrastructure) |
|
|
Primary Sponsor
|
| Name |
Dr Pavithra P |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital,Erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram-608002 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Pavithra P |
Government Dental College and Hospital, Cuddalore |
Department of Orthodontics and Dentofacial Orthopaedics,Government Dental College and Hospital,Cuddalore erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram
Cuddalore
TAMIL NADU |
07010495421
pavinandhi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital,Cuddalore district,Annamalai Nagar,608002,INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Burstone intrusion arch with helix |
Placement of conventional Burstone intrusion arch with helix for the intrusion of Maxillary incisors(Time Period: 6 months) |
| Intervention |
Mini Screw |
Placement of Mini Screw for the intrusion of Maxillary incisors(Time period:6 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Class I or Class II malocclusion
2.Adult patients 18 to 35 years of age both male and female
3.Deep bite cases with overbite equal to or more than 4 mm with excessive incisal display at rest and at smile
4.Average FMA angle
5.Patients with good oral hygiene
6.Patients with sound periodontal condition
|
|
| ExclusionCriteria |
| Details |
1.Skeletal deep bite cases
2.Missing teeth in the anterior maxillary area
3.Abnormal or Para functional habits
4.Any history of trauma to maxillary anterior teeth
5.Previous orthodontic treatment
6.Any systemic illness, hormonal disorder or syndromes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Rate of maxillary incisors intrusion between Mini screw and Burstone intrusion arch
with helix
2.Anchorage loss between Mini Screw and Burstone intrusion arch with helix
|
17 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dento skeletal and soft tissue changes between mini screw and burstone intrusion arch with helix
|
17 months |
Root resorption of maxillary anterior teeth between mini screw and burstone intrusion arch with helix
|
17 months |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
09/10/2024 |
| 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="5"
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
|
This study is a Randomized Controlled Parallel group trial to compare and evaluate the Rate of Maxillary incisors intrusion between Mini Screw and Burstone intrusion arch with helix in deep bite patients conducted in Department of Orthodontics, Government Dental College and Hospital Cuddalore.The primary outcome of the study is to assess and compare the rate of Maxillary incisors intrusion and also to assess and compare the Anchorage loss between Mini Screw and Burstone intrusion arch with helix.The Secondary outcome of the study is to assess and compare the Dentoskeletal and Soft tissue changes and also to assess and compare the Root resorption between Mini Screw and Burstone intrusion arch with helix.Total Time period of the study is 17 months.Total sample size was calculated to be 98 including the expected dropout rate of 20%. |