Evaluating the effect of Gentle Electrical Pulse Therapy in improving Jaw muscle strength and function

Phase 2

Not yet recruiting

Conditions: Anomalies of jaw-cranial base relationship,

Registration Number: CTRI/2025/05/087959

Lead Sponsor: All India Institute Of Medical Sciences

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 28

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Efficacy outcomes demonstrating NMES response rates, including stimulation-induced voluntary contractions of the masticatory muscles, leading to increased muscle strength and function.	Pre treatment,1 month,3 months,6 months
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute Of Medical Sciences
🇮🇳
Bathinda, PUNJAB, India
All India Institute Of Medical Sciences
🇮🇳Bathinda, PUNJAB, India
Dr Shifa Sulthana A J
Principal investigator
9544536706
ss.daffodilss@gmail.com