Health Condition 1: E638- Other specified nutritional deficiencies
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
MicrobioTx Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: For OSCC - histologically proven OSCC (oral biopsies) as per ICD-10-CM diagnosis codes (C04.9, C06.9) For Gingivitis with Halitosis - Gingivitis (acute/chronic) diagnosis as per ICD-10 diagnostic code K05.0-K05.1, Halitosis diagnosis as per ICD-10-CM R19.6 For Gingivitis without Halitosis- Gingivitis (acute/chronic) diagnosis as per ICD-10 diagnostic code K05.0-K05.1, Halitosis diagnosis non-confirmatory as per ICD-10-CM R19.6 For healthy - Absence of OSCC, Halitosis or gingivitis
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care) and Specificity: Specificity is defined as (number of microbes called deficient by both the standard of care and by MicrobioTx)/(number of microbes called deficient by standard of care)Timepoint: The single time point at which the data will be analysed will be 52 weeks from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Design probiotic formulation to improve oral microbial healthTimepoint: The single time point at which the data will be analysed will be 1.5 year from the start of the study. | — |
Countries
India
Contacts
Public ContactDr Palok Aich
MicrobioTx Health Private Limited
Outcome results
None listed