| CTRI Number |
CTRI/2022/01/039078 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the dentoskeletal changes following treatment for skeletal class III malocclusion using modified tandem appliance and facemask appliance among children of 7 to 12 year age group |
|
Scientific Title of Study
|
COMPARISON OF DENTOSKELETAL CHANGES IN THE TREATMENT OF SKELETAL CLASS III MALOCCLUSION USING MODIFIED TANDEM APPLIANCE AND FACE MASK APPLIANCE AMONG CHILDREN AGED 7 – 12 YEARS OLD – A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrArya S Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College |
| Address |
Department Of Pediatric And Preventive Dentistry, Government Dental College, Gandhinagar, Kottayam, Kerala
Kottayam
KERALA
686008
India |
| Phone |
9895790268 |
| Fax |
|
| Email |
aryaasok29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TV Anupam Kumar |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Government Dental College |
| Address |
Department Of Pediatric And Preventive Dentistry, Government Dental College, Gandhinagar, Kottayam, Kerala
Kottayam
KERALA
686008
India |
| Phone |
9746562556 |
| Fax |
|
| Email |
dentanupam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrArya S Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College |
| Address |
Department Of Pediatric And Preventive Dentistry, Government Dental College, Gandhinagar, Kottayam, Kerala
Kottayam
KERALA
686008
India |
| Phone |
9895790268 |
| Fax |
|
| Email |
aryaasok29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Kottayam, Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Arya S Kumar |
| Address |
Department Of Pediatric And Preventive Dentistry, Government Dental College Kottayam, kerala |
| 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 Arya S Kumar |
Government Dental College Kottayam |
Department Of Pediatric And Preventive dentistry
Kottayam
KERALA |
9895790268
aryaasok29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college Kottayam institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M261||Anomalies of jaw-cranial base relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Facemask Appliance |
Conventional orthopedic appliance used for early correction of skeletal class III malocclusion.Duration of therapy is 9 months. |
| Intervention |
Modified Tandem Appliance |
Newer orthopedic appliance used for early correction of skeletal Class III malocclusion.Duration of therapy is 9 months. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Established Skeletal class III malocclusion cases due to maxillary retrusion or combination of maxillary retrusion and mandibular prognathism.
2.Children of parents who are willing to participate in the study and who will be providing consent and children who will provide assent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with pseudo class III malocclusion.
2.Patients with mandibular excess.
3.Any pathological signs of external and internal resorption to teeth.
4.Children showing lack of cooperative behaviour.
|
|
|
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 |
| correction of reverse overjet |
7-8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time taken to correct reverse overjet |
7-8 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2022 |
| Date of Study Completion (India) |
24/12/2021 |
| 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
|
NIL |
|
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, parallel group outcome assessor blinded study, comparing dentoskeletal changes which occur in the treatment of skeletal class III malocclusion patients using modified tandem appliance and facemask appliance among children aged 7 to 12 years . The primary outcome is to compare the effectiveness of reverse overjet correction using both the appliance by cephalometric tracing. Secondary outcome is to asses the time taken to achieve the correction of overjet using both the appliance. |