| CTRI Number |
CTRI/2026/03/106688 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clear Aligners in Mixed dentition: A study on treatment outcomes and compliance, A new frontier in Indian population. |
|
Scientific Title of Study
|
Clear Aligners in Mixed dentition a study on treatment outcomes and compliance a new frontier in Indian population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANDAGALLA SRI THREYA |
| Designation |
POST GRADUATE ,PEDODONTICS |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY,VIKARABAD |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally ,opp. Shiv Sagar lake Vikarabad Telangana
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally, opp. Shiv Sagar lake Vikarabad Telangana
Hyderabad
TELANGANA
501102
India |
| Phone |
9154695013 |
| Fax |
|
| Email |
srithreya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY,VIKARABAD |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally, opp. Shiv Sagar lake Vikarabad Telangana
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally, opp.Shiv Sagar lake Vikarabad Telangana
Hyderabad
TELANGANA
501102
India |
| Phone |
9154695013 |
| Fax |
|
| Email |
sampathreddycheruku@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY,VIKARABAD |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally, opp. Shiv Sagar lake Vikarabad Telangana
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally, opp.Shiv Sagar lake Vikarabad Telangana
Hyderabad
TELANGANA
501102
India |
| Phone |
9154695013 |
| Fax |
|
| Email |
sampathreddycheruku@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SANDAGALLA SRI THREYA |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-641/1 AND 2 OPPOSITE SHIV SAGAR LAKE KOTHERPALLY VIKARABAD TELANGANA 501102 |
| 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 |
| S SRI THREYA |
SRI SAI COLLEGE OF DENTAL SURGERY Vikarabad Telangana |
SRI SAI COLLEGE OF DENTAL SURGERY 1-2-64/1 AND 2 Kothrepally opposite Shiv Sagar lake Vikarabad Telangana
Hyderabad
TELANGANA |
9154695013
srithreya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2024-25 |
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 |
Clear Aligner Therapy (Invisalign First or equivalent pediatric aligner system ) |
Patients in mixed dentition ages from 8 to 12 years with any malocclusion from mild to moderate type will be selected and be treated using clear aligners as an interceptive orthodontic treatment plan.Aligners will be fabricated using digital intra oral scans or study models of the patients selected according to their type of malocclusion . Patients will be instructed to wear aligners for 20 to 22 hours per day and change them as per manufacturer guidelines . Treatment progress will be monitored periodically . pre treatment (t0)and post treatment(t1) and arch analysis will be performed to assess intercanine width intermolar width , arch length ,arch perimeter and arch depth for pre to post operative changes . patient compliance will be assessed using log sheets and interviews . |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients in mixed dentition with minimum 4 erupted permanent incisors and first permanent molars. Mild to moderate crowding or spacing less than equal to 4 mm. Presence of minor rotations or cross bite .Written informed consent obtained from parents or guardians. |
|
| ExclusionCriteria |
| Details |
Severe skeletal discrepancies.Syndromic or medically compromised patients.Patients with previous orthodontic treatment.Non compliant patients.Posterior cross bite requiring skeletal correction.Partially erupted teeth. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dental arch dimensions (intercanine width, intermolar width, arch length, and arch perimeter) from pretreatment (T0) to post-treatment (T1) following clear aligner therapy in mixed dentition patients. |
Baseline (T0 – pretreatment) and Post-treatment (T1 – after completion of aligner therapy) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in arch depth, space discrepancy, and trans palatal width from T0 to T1; patient compliance during treatment; and patient satisfaction at T1. |
Baseline (T0) and post-treatment (T1, after completion of aligner therapy). |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 focuses on the benefits of using clear aligners in mixed dentition phase as an early intervention in treating mild to moderate malocclusions. Mixed dentition represents a critical phase in the oral development of pediatric patients characterized by simultaneous presence of primary and permanent teeth. This study is effective in the application of aligners as an innovative methodology in managing mixed dentition. The primary objective is to explore the efficacy, safety and acceptability of this emerging orthodontic technology in the evolving age group. Clear aligners have gained popularity due to their aesthetics and hygiene benefits. However, limited studies have focused on the immediate changes in the dental arch following clear aligner therapy in children. This study aims to prove effectiveness of the clear aligners by using arch analysis which can serve as a quantitative tool to assess treatment progress in terms of arch length, width, perimeter and tooth alignment. |