| CTRI Number |
CTRI/2025/03/083305 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study of changes in the bone surrounding the teeth when all the teeth are moved back vs moving back the front teeth alone in a condition of forwardly placed teeth using braces. |
|
Scientific Title of Study
|
Alveolar bone remodelling in enmasse maxillary distalization vs enmasse anterior maxillary retraction |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Botta Geetha prasanna |
| Designation |
post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Sibar Institute of Dental Sciences.
Department of Orthodontics and Dentofacial Orthopedics.
Takkellapadu Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9985654789 |
| Fax |
|
| Email |
geethaprasannadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Devikanth |
| Designation |
Professor, Department of Orthodontics and Dentofacial Orthopedics. |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Sibar Institute of Dental Sciences.
Department of Orthodontics and Dentofacial Orthopedics.
Takkellapadu Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9030330839 |
| Fax |
|
| Email |
dr.devikanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Botta Geetha prasanna |
| Designation |
post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Sibar Institute of Dental Sciences.
Department of Orthodontics and Dentofacial Orthopedics.
Takkellapadu Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9985654789 |
| Fax |
|
| Email |
geethaprasannadr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Botta Geetha Prasanna |
| Address |
1st year post graduate, Sibar Institute of Dental Sciences.
Department of Orthodontics and Dentofacial Orthopedics.
Takkellapadu Guntur.
|
| 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 |
| DrBotta Geetha prasanna |
Sibar institute of dental sciences |
Room no-6, Department of orthodontics and dentofacial orthopedics.
Guntur
ANDHRA PRADESH |
9985654789
geethaprasannadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SIBAR INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Enmasse maxillary distalization
2. Enmasse anterior maxillary retraction
|
comparing Enmasse maxillary distalization procedure with Enmasse anterior maxillary retraction. Total duration 12months |
| Comparator Agent |
1.Enmasse maxillary distalization 2. Enmasse anterior maxillary retraction
3. Cbct analysis |
comparing Enmasse maxillary distalization procedure with Enmasse anterior maxillary retraction |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with end on molar and canine relationship.
2. Significant overjet of 6mm.
3.Fully erupted maxillary and mandibular molars and erupting third molars.
4.No symptoms of TMJ disorders.
|
|
| ExclusionCriteria |
| Details |
1.Patients with active periodontal diseases.
2.History of bone loss.
3.Systemic medical conditions that impact bone metabolism or healing.
4.Severe crowding that necessitates additional extractions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
alveolar bone thickness
alveolar bone inclination |
after 3 months of the completion of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Alveolar bone changes in the anterior region
Alveolar bone changes in the posterior region |
3 months after the completion of the procedure |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
11/09/2025 |
| 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="0"
Months="11"
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
|
The study will be conducted on patients visiting department of Orthodontics and dentofacial Orthopedics, Sibar institute of dental sciences. Patients willing to participate in the study will be divided into two equal groups (n = 12/ group). Group1 consists of subjects undergoing Maxillary arch distalization into second molar extraction site while, group 2 involved en- masse maxillary anterior retraction into first premolar extraction site. This study is aiming to evaluate and compare the extent and pattern of alveolar bone remodeling in patients undergoing Maxillary arch distalization and Enmass maxillary anterior retraction. |