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Use of ultrasound technique to increase reduced mouth opening due to habits like tobacco and gutka consumption

Effectiveness of mouth opening exercises with and without therapeutic ultrasound in increasing mouth opening in OSMF patients – A Randomized Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056053
Enrollment
30
Registered
2023-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Therapeutic ultrasound plus mouth opening exercises: Patients will be taught mouth opening exercises along with 8 sessions of therapeutic ultrasound delivered every third day with each

Sponsors

Dr Vijayalakshmi K R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects between 18 to 60 years of age without gender bias. 2. Subjects with clinical stage 1, 2 or 3 and functional stage 2, 3, or 4 according to More et al (2012) classification

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating subjects. 2. Subjects presenting open or infected wound, eczema in the region of masseter muscle where ultrasound has to be administered. 3. Subjects with dental implants or abscess in the area of ultrasound application. •Subjects having vascular diseases, cardiac diseases, or cardiac pacemakers. •Subjects undergoing treatment for OSMF or any other oral potentially malignant disorder (OPMD) or other systemic pre-cancerous or cancerous conditions. •Subjects with decreased mouth opening for reasons other than OSMF like pericoronitis, post-extraction trismus. •Subjects with missing maxillary and/ or mandibular incisors.

Design outcomes

Primary

MeasureTime frame
Increase in mouth openingTimepoint: 0, 4 weeks

Secondary

MeasureTime frame
Tongue protrusion Cheek flexibility VAS scoreTimepoint: 0, 4 weeks

Countries

India

Contacts

Public ContactDr Vanshika Jain

Government Dental College and Research Institute Bangalore

vanshikajain13@gmail.com9818461796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026