To determine the levels of Supari nut ingredients in current and past Suapri users
- Conditions
- Health Condition 1: R888- Abnormal findings in other body fluids and substancesHealth Condition 2: K117- Disturbances of salivary secretion
- Registration Number
- CTRI/2021/01/030290
- Lead Sponsor
- AIIMS Intramural Research Section
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Current users
1 Subjects with self -reported current history of consuming betel nut and betel nut containing products
2 The duration of consumption of betel nut and betel nut containing products is more than 1 month.
3 Subjects willing to participate in the study
Past users
1 Subjects with self -reported past history of consuming betel nut and betel nut containing products
2 The duration of abstinence from of betel nut and betel nut containing products is more than 1 month.
3 Subjects willing to to participate in the study
Control group
1 Subjects with no self ââ?¬â?? reported past/ current history of consuming betel nut and betel nut containing products, smoking/ smokeless tobacco and alcohol
2 Subjects without any oral potentially malignant disorder
Current / Past users and Control group
1 Subjects with presence / history of previous treatment for any suspicious malignant oral lesions or any other malignancies
2 Subjects with significant serious uncontrolled systemic disorders
3 History of using any medications affecting salivary composition and flow.
4 Patients with recent history of using any common medications affecting salivary flow and composition like antihypertensives,antihistamines, antidepressants, antipsychotics, antiemetics, antispasmotics, and anti-parkinsonian drugs. Any systemic illness affecting salivary flow and composition like diabetes/ endocrine disorders, xerostomia, burning mouth syndrome, radiation/ chemotherapy, auto immune disorders like sjogrens syndrome and salivary gland disorders.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Concentration of Betel nut extracts in current and past betel nut users <br/ ><br>Corelation between Betel nut extracts and Pro-oncogenic cytokines in betel nut users <br/ ><br>Exfoliated mucosal cells as an alternative method for determination of Betel Nut extractsTimepoint: after 3 years
- Secondary Outcome Measures
Name Time Method se of this method to determine success of Betel nut cessation programs <br/ ><br>Therapeutic interventions to change salivary pH and prevent entrapment of Betel nut extracts in oral tissue banks and expedite their secretion in salivaTimepoint: at 5 years