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Correlation analysis of curcumin gel during treatment in patients with oral submucosal fibrosis

Phase 1
Conditions
oral submucous fibrosis(OSF)
Registration Number
ChiCTR2400088810
Lead Sponsor
Hunan Xiangya School of Stomatology, Central South University (Xiangya Stomatological Hospital)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) In line with the diagnostic criteria for Oral Submucosal fibrosis (Trial draft) Cause: The subjects had a history of chewing betel nut. Symptoms: burning of the oral mucosa, pain from eating irritating food, blisters on the mucosa of the soft palate, blisters bursting and forming small ulcers, impaired taste, tongue movement disorders, difficulty swallowing and restricted mouth opening. Signs: The focal or whole oral mucosa is grayish white, the mucosa is rough like leather, there are fiber lines in the inferior pterygocollar ligament area and the soft palate, the lingual papilla is atrophic, and the mouth opening is small.) Or study subjects with pathological diagnosis of OSF; <br>(2) Age 18-60 years old; <br>(3) Those who have not used immunomodulators or hormone drugs within three months. <br>(4) Voluntarily participate in and sign informed consent, which mainly includes informed consent for disease examination methods and auxiliary treatment programs.

Exclusion Criteria

(1) Allergic to curcumin or other gel ingredients; <br>(2) oral mucosa with malignant diseases such as cancerous ulcers <br>(3) pregnant and lactating women; <br>(4) People with mental illness or cognitive impairment; <br>(5) Those who cannot take medication as prescribed by the doctor and return to the doctor on time; <br>(6) Suffering from other local or systemic diseases.

Study & Design

Study Type
Health Services Research
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mucosal texture score;
Secondary Outcome Measures
NameTimeMethod
mouth opening;Mucosal pain index;Mucosal color score;
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