| CTRI Number |
CTRI/2025/12/099459 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing three types of orthodontic appliances to correct front teeth malocclusion in children. |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical and Oral Health Parameters during Three Orthodontic Appliances treatment in Children with Mixed Dentition Stage for Correction of Anterior Crossbite |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thaslima Nandhini JS |
| Designation |
Postgraduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive dentistry
Chettinad Dental college and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Chennai
TAMIL NADU
603103
India |
| Phone |
9952092520 |
| Fax |
|
| Email |
thasnandhu1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nancy |
| Designation |
Reader |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive dentistry
Chettinad Dental college and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Chennai
TAMIL NADU
603103
India |
| Phone |
9940176726 |
| Fax |
|
| Email |
nancysolomon94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nancy |
| Designation |
Reader |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive dentistry
Chettinad Dental college and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Chennai
TAMIL NADU
603103
India |
| Phone |
9940176726 |
| Fax |
|
| Email |
nancysolomon94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
6B Pediatric and Preventive dentistry
Chettinad Dental college and Research Institute
Rajiv Gandhi salai, Padur, Kelambakkam
Chennai 603103
Tamil Nadu
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Thaslima Nandhini J S |
Chettinad Dental College and Research Institute |
6B Paediatrtic and Preventive dentistry
Chettinad Dental college and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Chennai
TAMIL NADU |
9952092520
thasnandhu1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children with age group of 7-11 years (mixed dentition with anterior crossbite) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clear aligners |
streptococcus mutans colony count
gingival index and plaque index will be measured at baseline 1 month and 2 months |
| Intervention |
fixed appliances |
streptococcus mutans colony count gingival index and plaque index will be measured at baseline 1 month and 2 months |
| Intervention |
Removable appliances |
streptococcus mutans colony count gingival index and plaque index will be measured at baseline 1 month and 2 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 7-11 years of both the gender children, who reported with their parents or legal guardian.
2. ASA I - A normal healthy patient with no systemic disease.
3. Children with the primary complaint of malocclusion
4. Children during mixed dentition period.
5. Skeletal and dental class I
6. Single tooth / multiple teeth
7. lack of antibiotic therapy during the 3 months prior
8. A parent (or guardian) signed a written consent for the therapy and the clinical trial.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised and developmentally disabled children
2. Children with a documented history of oral or maxillofacial trauma.
3. children with developmental anomalies or disturbances of face / pathologies in head and neck region / tumour
4. with acute pain or swelling.
5. Patient with high caries risk
6. Patient with Localised Aggressive Periodontitis / Juvenile Periodontitis
7. Patient with history of extraction of permanent teeth due to caries or periodontitis
8. No extensive dental restorations or fixed partial dentures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure the clinical and oral health parameters in children with mixed dentition. |
baseline 1 month and 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
02/01/2026 |
| 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="6"
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
|
1. This study is a randomized, single blinded, parallel group, multiple arm trial to evaluate the plaque and calculus, the stage of gingivitis and microbial colony count of S mutans during three orthodontic appliance techniques in children with mixed dentition in age group of 7-11 years. The primary outcome measures will be assessed at the baseline (0 month) during (1 month) and after the treatment (2 month). |