| CTRI Number |
CTRI/2025/05/087959 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effect of Gentle Electrical Pulse Therapy in improving Jaw muscle strength and function |
|
Scientific Title of Study
|
Assessing the Impact Of Electrical Stimulation on Masticatory Muscles in Myofunctional Appliance Therapy: A Randomized Controlled Trial
|
| 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 Shifa Sulthana A J |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 3014
Division Of Orthodontics and Dentofacial Orthopaedics Department Of Dentistry
C Block OPD
All India Institute Of Medical Sciences
Bathinda Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
9544536706 |
| Fax |
|
| Email |
ss.daffodilss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Singh Rana |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 3015
Division Of Orthodontics and Dentofacial Orthopaedics Department Of Dentistry
C Block OPD
All India Institute Of Medical Sciences
Bathinda Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
8750146251 |
| Fax |
|
| Email |
rana.shailu0612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shifa Sulthana A J |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences Bathinda |
| Address |
Room No 3014
Division Of Orthodontics and Dentofacial Orthopaedics Department Of Dentistry
C Block OPD
All India Institute Of Medical Sciences Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9544536706 |
| Fax |
|
| Email |
ss.daffodilss@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences
Mandi Dabwali Road
Jodhpur Romana
Bathinda 151001
Punjab
India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
All India Institute Of Medical Sciences
Mandi Dabwali Road
Jodhpur Romana
Bathinda 151001
Punjab |
| 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 Shifa Sulthana A J |
All India Institute Of Medical Sciences |
Room No 3014
Division Of Orthodontics and Dentofacial Orthopaedics
Department Of Dentistry
C Block
OPD
Bathinda
PUNJAB |
9544536706
ss.daffodilss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute Of Medical Sciences Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M261||Anomalies of jaw-cranial base relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Twin Block patients with Neuromuscular Electrical Stimulation (NMES) |
Group 1 subjects will be provided with Neuromuscular Electrical Stimulation on the Masseter,Temporalis and Anterior digastric muscles bilaterally starting from the day of Twin Block appliance insertion. During stimulation the appliance should not be worn as the muscles should be in relaxed state.
The interventions will be provided 3 days per week, 30 minutes per day done by a physiotherapist using Physiotrack Mini Stimulator(Mini MS) 2 channel Machine for the first day of intervention and then the patient should continue providing stimulation at home for upto 8 weeks.
Group 1 patients will be subjected to evaluation with surface Electromyography (sEMG) of Masseter, Temporalis and Anterior Digastric muscles bilaterally to determine the change in neuromuscular activity using 8-channel EMG System Model Neurosoft MEP8 machine, with and without wearing the Twin Block appliance starting from the day of appliance insertion (Pre treatment), then follow up at 1 month , 3 months and 6 months in three different positions for each muscle (at Postural rest position, during Maximal clenching and Saliva swallowing).
Group 1 patients will also be subjected to evaluation with Ultrasonography (USG) of Masseter, Temporalis, Lateral pterygoid and Anterior digastric muscles bilaterally to determine the change in muscle structure using X CUBE 70 USG machine(SL3-19H linear probe) with and without wearing the Twin Block appliance starting from the day of appliance insertion (Pre treatment) ,then follow up at 1 month and 6 months in three different positions (at Postural rest position for Temporalis, Maximal clenching for Masseter, Mouth opening position for Lateral pterygoid and Anterior digastric muscles).
|
| Comparator Agent |
Group 2- Twin Block patients without Neuromuscular Electrical Stimulation (NMES) |
Group 2 subjects will not receive Neuromuscular Electrical Stimulation as they are the control group.
But they will be subjected to evaluation by surface Electromyography (sEMG) of Masseter, Temporalis and Anterior Digastric muscles bilaterally with and without wearing the Twin Block appliance starting from the day of appliance insertion (Pre treatment), then follow up at 1 month , 3 months and 6 months in three different positions for each muscle (at Postural rest position, during Maximal clenching and Saliva swallowing).
Group 2 patients will also be subjected to evaluation with Ultrasonography (USG) of Masseter, Temporalis, Lateral pterygoid and Anterior digastric muscles bilaterally with and without wearing the Twin Block appliance starting from the day of appliance insertion (Pre treatment) ,then follow up at 1 month and 6 months in three different positions (at Postural rest position for Temporalis, Maximal clenching for Masseter, Mouth opening position for Lateral pterygoid and Anterior digastric muscles). |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Skeletal Class II division 1 malocclusion with retrognathic mandible
2. Increased overjet not less than 5mm
3. Mixed or permanent dentition
4. Positive pre-treatment Visualized Treatment Objective(VTO)
5. Minimum crowding in dental arch requiring no extraction of any permanent teeth
6. Patients giving consent for participating in the study
|
|
| ExclusionCriteria |
| Details |
1.History of previous orthodontic treatment
2.Class II division 2 malocclusion
3.Any systemic disease affecting bone and general growth
4.Presence of any craniofacial syndromes
5.Presence of Temporomandibular Joint disorders
6.Presence of neuromuscular disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy outcomes demonstrating NMES response rates, including stimulation-induced voluntary contractions of the masticatory muscles, leading to increased muscle strength and function.
2. Identification of physiological parameters that predict treatment response and provide insight into resistance mechanisms, potentially guiding future therapeutic strategies for optimizing NMES effectiveness in masticatory muscle rehabilitation. |
Pre treatment,1 month,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of improvements in facial profile or functional jaw performance induced by NMES-based retraining of masticatory muscles. |
Pre treatment,1 month,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 2 |
|
Date of First Enrollment (India)
|
02/07/2025 |
| 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="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
|
The aim of this research is to evaluate the impact of NMES (Neuromuscular Electrical Stimulation) on masticatory muscles in conjunction with Twin Block therapy, utilizing surface Electromyography (sEMG) and Ultrasonography (USG) to quantify treatment efficacy and muscle performance. The main hypothesis of this Randomized Controlled Trial is to assess the role of Electrical Stimulation on masticatory muscles in altering the muscle strength and function during Twin Block Myofunctional appliance therapy in Class II division 1 malocclusion patients of 9-14 yrs of age and comparing the results with the patients undergoing Twin Block Myofunctional appliance therapy not receiving electrical stimulation. |