| 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
|
|
|
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
|
|
|
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. |