Presence of Fungus in individuals with split lip and palate

Incidence and Prevalence of Oral Candidal Colonization in Patients with Cleft Lip and Palate

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029821

Enrollment

100

Registered

2020-12-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: swab collection from cleft lip and palate patients: a sterile swab will be brushed gently along with the buccal mucosa, floor of mouth, palate and tongue, the swab will be then cultured

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactImran khan

Jamia Millia Islamia

nmanzoor@jmi.ac.in9958756661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026