Health Condition 1: R888- Abnormal findings in other body fluids and substances Health Condition 2: K117- Disturbances of salivary secretion
Conditions
Interventions
None listed
Sponsors
AIIMS Intramural Research Section
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of Betel nut extracts in current and past betel nut users Corelation between Betel nut extracts and Pro-oncogenic cytokines in betel nut users Exfoliated mucosal cells as an alternative method for determination of Betel Nut extractsTimepoint: after 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of this method to determine success of Betel nut cessation programs 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 | — |
Countries
India
Contacts
Public ContactDr Shalini Gupta
CDER All India Institute of Medical Sciences
Outcome results
None listed