| CTRI Number |
CTRI/2025/06/088319 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to know the skeletal and dental effects of two treatment methods - SEFA III and SEA III for growing patients from 9 to 14 years age group with upper and lower jaw growth differences |
|
Scientific Title of Study
|
Comparison of two treatment protocols - SEFA III and SEA III for developing dentoskeletal Class III correction - an institutional based randomized clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chelsia G Kulathinal |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College Calicut |
| Address |
Room no.21
PG Clinic
Department of Orthodontics
Government Dental College
Calicut
Pin 673008
Kozhikode
KERALA
673008
India |
| Phone |
9496663441 |
| Fax |
|
| Email |
kulathinalchelsiag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen S |
| Designation |
Professor |
| Affiliation |
Government Dental College Calicut |
| Address |
Room no.21
PG Clinic
Department of Orthodontics
Government Dental College
Calicut
Pin 673008
Kozhikode
KERALA
673008
India |
| Phone |
9846274491 |
| Fax |
|
| Email |
orthonair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen S |
| Designation |
Professor |
| Affiliation |
Government Dental College Calicut |
| Address |
Room no.21
PG Clinic
Department of Orthodontics
Government Dental College
Calicut
Pin 673008
Kozhikode
KERALA
673008
India |
| Phone |
9846274491 |
| Fax |
|
| Email |
orthonair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Kozhkode,Government Medical College Campus,Kozhikode,Kerala 673008 |
|
|
Primary Sponsor
|
| Name |
Chelsia G Kulathinal |
| Address |
Room no.21
PG Clinic
Department of Orthodontics
Government Dental College
Calicut
Pin 673008 |
| Type of Sponsor |
Other [PRINCIPAL INVESTIGATOR] |
|
|
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 |
| Chelsia G Kulathinal |
Government Dental College Calicut |
Room no.21
PG Clinic
Department of Orthodontics
Government Dental College
Calicut
Pin 673008
Kozhikode
KERALA |
9496663441
kulathinalchelsiag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,Government Dental College,Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SEA III -Splints,Class III elastics,Alternate Rapid Maxillary Expansion and Constriction |
SEFA III is compared with a modified protocol including only intra oral components namely, Fixed maxillary splint ,removable mandibular splint,class III extra oral elastics,Alternate Rapid Maxillary expansion and constriction for loosening of mid palatal suture and expanding and advancing of maxilla |
| Comparator Agent |
SEFA III including Splints,class III elastics,Alternate Rapid Maxillary Expansion and Constriction and facemak |
For correcting Class III,already existing treatment SEFA III appliance including following components are given.Fixed maxillary splint,removable mandibular splint,Class III elastics,Alternate Rapid maxillary expansion and constriction for loosening of midpalatal suture and expanding maxilla.Facemask is also given 14-16 hrs |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1)Deciduous or Mixed dentition
2)Angle’s Class III Molar relationship
3)Anterior Cross bite / Edge to edge
4)Wits appraisal of less than or equal to 2.0 mm and ANB less than or equal to 3 degrees
5) Skeletal maturation CS3 stage |
|
| ExclusionCriteria |
| Details |
1) Craniofacial malformations and/or syndromes
2)Previous orthopedic/orthodontic treatments. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome measures the skeletal and dental dimensional changes in Class III patients following SEFA III
protocol and a group of patients who had undergone SEA III protocol using conventional
cephalometric analyses, standard reference points and planes in 1 year. |
secondary outcome mesures the skeletal and dental dimensional changes in Class III patients following SEFA III
protocol and a group of patients who had undergone SEA III protocol using conventional
cephalometric analyses, standard reference points and planes at baseline(T1) and after 1 year(T2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the soft tissue dimensional changes in Class III patients following SEFA III
protocol and a group of patients who had undergone SEA III protocol using conventional
cephalometric analyses, standard reference points and planes. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| Date of Study Completion (India) |
01/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dentoskeletal class III malocclusion is characterized as increased growth of lower jaw or deficient growth of upper jaw or the combination. Most of the cases, the malocclusion is accompanied by dental compensations. The objective of this study is to compare the effectiveness of two treatment protocols- SEA III (involving only intra oral appliances) and SEFA III (involves intra oral and extra oral appliances).The research will be conducted in the Department of Orthodontics and Dentofacial Orthopedics at Government Dental College, Kozhikode.
This study is a randomized double blind, parallel group trial comparing efficacy of two treatment protocols for treating developing dentoskeletal class III corrections - SEA III and SEFA III.SEA III includes maxillary and mandibular splints, class III elastics, Alternate Rapid Maxillary Expansion and Constriction for 7 weeks. SEFA III protocol includes maxillary and mandibular splints, class III extra oral elastics, Alternate Rapid Maxillary Expansion and Constriction for 7 weeks and facemask for 14 - 16 hours. Primary outcomes are skeletal and dental dimensional changes in Class III patients following SEFA III protocol and a group of patients who had undergone SEA III protocol using conventional cephalometric analyses, standard reference points and planes at 1 year. Secondary outcomes are the soft tissue dimensional changes in Class III patients following SEFA III protocol and a group of patients who had undergone SEA III protocol using conventional cephalometric analyses, standard reference points and planes at 1 year.
Data will be computerized, and statistical analysis will be conducted using the Statistical Package for Social Sciences software for Windows. Quantitative variables will be summarized as mean and standard deviation. A paired and unpaired T test will be employed to compare the values before and after treatment(p>0.05).
If a significant result is observed in the SEA III group, the integration of the treatment protocol involving intra oral appliance alone may be considered for the future. |