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CTRI Number  CTRI/2026/03/105837 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Changes in speech after twin block appliance treatment in children with recessive mandible 
Scientific Title of Study   Acoustic comparison of speech in growing children with skeletal class II malocclusion before and after mandibular advancement using twin block appliance: an experimental 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  Dr Jyoti Manchanda 
Designation  Associate Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospital, Medical Square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9423188175  
Fax    
Email  drjyotimadaan@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Santosh Chavan 
Designation  Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospital, Medical Square, Nagpur


MAHARASHTRA
440003
India 
Phone  9823630486  
Fax    
Email  drsjchavan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Manchanda 
Designation  Associate Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  104, Department of Orthodontics, Government Dental College and Hospital, Medical Square, Nagpur


MAHARASHTRA
440003
India 
Phone  9423188175  
Fax    
Email  drjyotimadaan@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Jyoti Manchanda 
Address  104, Department of Orthodontics, Government Dental College and Hospital, Nagpur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Orthodontic Society  CENTER FOR ADVANCED DENTAL CARE, VPS 21, TOP FLOOR SHIPRA KRISHNA VISTA PLAZA INDIRAPURAM,Ghaziabad 201014 INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoti Manchanda  Government Dental College and Hospital, nagpur  104, 1st floor, Department of Orthodontics, Government Dental College and Hospital, Medical Square, Ajni, Nagpur
Nagpur
MAHARASHTRA 
9423188175

drjyotimadaan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Dental College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having Skeletal Class 2 malocclusion with retrognathic mandible 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Twin block appliance  Myofunctional appliance used for treating skeletal class 2 with retrognathic mandible. Treatment period is 6 to 9 months.  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Clinically:
a) Subject with a full cusp class II or end-on molar relationship bilaterally with convex facial profile.
b) Overjet more than 5mm.
c) Patients in whom clinical VTO (Visual treatment objective) improves with anterior positioning of mandible.

Radiographically:
a) A pre-treatment cephalometric analysis with ANB angle more than 4 degrees with favourable functional analysis and favourable growth pattern.
b) Subjects who are in accelerated phase of pubertal growth spurt (MP3-FG and MP3-G stage). 
 
ExclusionCriteria 
Details  a) Subject who had a previous history of any orthodontic treatment
b) Missing teeth, Supernumerary teeth, Presence of anterior open bite or cross bite
c) Nasal stenosis due to structural problems.
d) Severe cognitive or communication impairments
e) Currently in speech therapy or any history of speech therapy
f) Syndromic or cleft lip and palate cases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in acoustic characteristics of speech  T0: Baseline (before initiation of Twin Block appliance therapy)
T1: After completion of Twin Block appliance therapy (6 months)
T2: 9 months from baseline (T0) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in craniofacial morphology  T0: Baseline (before treatment)
T1: After completion of Twin Block therapy (6 months)
T2: 9 months from baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/04/2026 
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="2"
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 aims to evaluate the effect of mandibular advancement using the Twin Block appliance on the acoustic characteristics of speech in children with skeletal Class II malocclusion. Skeletal Class II malocclusion commonly caused by mandibular retrognathism may influence oral cavity configuration and potentially affect speech production. Functional appliances such as the Twin Block are widely used in growing patients to advance the mandible and improve jaw relationships. However limited evidence is available regarding their impact on speech acoustics.

This experimental before and after study will include children aged 10 to 14 years with skeletal and dental Class II malocclusion reporting to the Department of Orthodontics. Baseline records including clinical examination study models cephalometric radiographs photographs and speech recordings will be obtained before treatment T0. Participants will undergo mandibular advancement therapy using a Twin Block appliance. Follow up records will be obtained after completion of Twin Block therapy at 6 months T1 and again at 9 months from baseline T2.

Speech samples will be recorded in a quiet environment using a condenser microphone and analyzed using Praat software. Acoustic parameters including fundamental frequency F0 and formant frequencies F1 F2 and F3 for vowels a i and u will be measured. Cephalometric parameters and dental measurements will also be recorded to assess changes in craniofacial morphology and occlusion.

The study will compare acoustic speech characteristics before and after Twin Block therapy and evaluate the correlation between changes in speech parameters and craniofacial morphological changes following mandibular advancement treatment.

 
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