Presence of Fungus in individuals with split lip and palate

Phase 1

• Conditions: Health Condition 1: Q188- Other specified congenital malformations of face and neck

• Registration Number: CTRI/2020/12/029821
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients with Cleft lip Palate (CLP) and with absence of any systemic disease/any other syndrome.

2) Non smoker/ No other Negative Oral Habits. (i e Tobacco, Gutkha, Pan Masala Chewing)

3) No Clinical Signs of Pre malignant lesions such as Leukoplakia, Lichen Planus, OSMF.

4) No Clinical sign of Oral Candidiasis.

5) No ongoing or previous prolonged use of immunosuppressive medications such as steroids

Exclusion Criteria

1)Patients with pre existing Oral Candidiasis.

2)Patients or Parents (in case of minors) unwilling to take part in study.

3)Patient taking long term steroid therapy or any immunosuppreisve drugs.

4)Smokers, patients with habits of tobacco chewing, Gutka, pan masala Chewing.

5)Patients with existing oral premalignant lesions like leukoplakia, lichen planus, oral submucos fibrosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the colonization rate of oral Candida species and the influence of age, gender, oral <br/ ><br>health status, number of surgeries, and type of cleft.Timepoint: Patient Identification:- 3 months <br/ ><br>Swab Collection:- 3 months <br/ ><br>Culture Report Configuration and assessment:- 3 months <br/ ><br>Data Analysis :- 3 months <br/ ><br>manuscript writing and publication :- 6 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess the incidence rate of oral Candida species and the influence of age, gender, oral <br/ ><br>health status, number of surgeries, and type of cleft.Timepoint: Patient Identification:- 3 months <br/ ><br>Swab Collection:- 3 months <br/ ><br>Culture Report Configuration and assessment:- 3 months <br/ ><br>Data Analysis :- 3 months <br/ ><br>manuscript writing and publication :- 6 months <br/ ><br>