Soft tissue manipulation in patients with restricted mouth opening.

Phase 2/3

Not yet recruiting

Conditions: Oral submucous fibrosis,

Registration Number: CTRI/2023/07/054716

Lead Sponsor: Rohan Kumar Sahu

Brief Summary: Oral submucous fibrosis (OSMF) is a sneaky, long-lasting, and potentially cancerous condition of the oral cavity. Submucosal fibrosis, which affects the majority of the oral cavity, and increasing trismus from tight lips, cheeks, pharynx, and upper third of esophagus that causes dysphagia and a burning feeling in the mouth are the diseaseâ€™s hallmarks. Symptoms of oral submucous fibrosis include pain, ulceration, and a burning sensation in the oral mucosa. Estimates place Indiaâ€™s prevalence at 1.2-4.6% in women and 0.2-2.3% in men. Micronutrient deficits, an excessive consumption of areca nuts, and capsaicin in chillies are etiological variables. The purpose of current study will to determine the effect of soft tissue manipulation and to know the function and muscle activity of superficial masseter and anterior temporalis muscle. It will be the two group pre-test post-test experimental design. The patients of Oral Submucous Fibrosis will be recruited based on inclusion and exclusion criteria. The patients will be randomly allocated to two groups, group 1 and 2. The experimental group (group 1) will receive soft tissue manipulation + intralesional medication, while the clinical group (group 2) will receive only intralesional medication. The patients of group 1 (experimental group) will be treated with intralesional medication once in a week for 6 weeks, along with soft tissue manipulation for twice a week for half an hour each session. After 2 weeks of treatment, a temporo-mandibular joint distraction and compression technique will also add which increased the treatment time to 35 min. Assessment will take at baseline, after 3 weeks and after 6 weeks. The patients of group 2 (clinical group) will be intervened by only intralesional medication. This study will help clinicians to incorporate soft tissue manipulation as a part of their treatment plan in patients with Oral Submucous Fibrosis. The estimated sample size will be calculated by conducting a pilot study. The collected data will be analyzed by using SPSS 20.0 version. Data analysis will be done with the help of Shapiro Wilk /Kolmogorov Smirnov test. Parametric/Non-parametric tests will be used accordingly. For within the group analysis, paired t-test/ Wilcoxon Signed Rank test will be used. For between group analysis, independent t-test/Mann-Whitney U test will be used.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Individuals with OSMF.
Both male and female participants.

Exclusion Criteria

Patients with infections and inflammatory causes responsible for trismus.
Trauma to the maxillofacial skeleton.
Dermatomyositis Scleroderma.
Gingivitis and periodontitis.
Parafunctional habits.
Patients who are unable to give consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mouth Opening Function	Baseline \| 3 weeks \| 6 weeks

Secondary Outcome Measures

Name	Time	Method
EMG	Baseline
NPRS	Baseline

Trial Locations

Locations (1): Musculoskeletal Physiotherapy Research lab MMIPR Mullana Ambala.
🇮🇳
Ambala, HARYANA, India
Musculoskeletal Physiotherapy Research lab MMIPR Mullana Ambala.
🇮🇳Ambala, HARYANA, India
Rohan Kumar Sahu
Principal investigator
7582927554
rohansahu512@gmail.com