Prevention and Treatment of Oral Candidiasis Among Pediatric HIV Patients

Phase 4

Completed

Conditions: HIV positive pediatric patients

Registration Number: CTRI/2011/12/002212

Lead Sponsor: AB Shetty memorial institute of dental science mangalore

Brief Summary: The purpose of this study is to evaluate the outcome of chlorhexidine mouthwash in prevention and treatment of oral candidiasis HIV child patients above 6 years and below 18 years. Background & objectives:

A study was conducted in two rehabilitation centers at Mangalore with an aim to determine the microbiological and clinical effectiveness of Chlorhexidine Gluconate 0.2% as an antifungal agent in pediatric HIV patients and also to determine clinical correlation of oral manifestations and clinical efficacy of Chlorhexidine Gluconate 0.2% as a prognostic marker in pediatric HIV patient with different CD4 cell counts.

Study design:

This was a clinical study conducted on 30 HIV+ve children. Inclusion in the study was based on oral examination and positive oral culture for Candida. At baseline, 25 subjects with no clinical lesions but who were culture-positive for Candida were placed on preventive therapy of CHX once daily for 90 days. 5 Subjects with clinical oral candidiasis were placed on therapeutic CHX twice daily. All 30subjects received regular oral exams at 30th, 60th and 90th day intervals. At 90 days oral swabs were again taken for Candida. Colony-forming units (CFU) were determined before and after CHX treatment.

**Results:**

Of 30 culture-positive subjects all were included in theCFU analyses. After 90 days of CHX oral rinse therapy, 21 Subjects achievedcomplete elimination of CFU at the end of 90 days. In 18 subjects candidaalbicans were undetectable at the end of 90 days and 4 subjects had 10 foldreduction in the colonies after 90 days, though a complete elimination was notpossible among them.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.HIV positive pediatric patients.
2.CFU greater than 5.
3.Not on any systemic medication since one month.
4.Only pseudo membranous or erythematous candidiasis.

Exclusion Criteria

1.On systemic medication.
2.CFU less than 5.
3.Any other type of candidiasis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevention and treatment of oral candidiasis among pediatric HIV positive patients using chlorhexidine gluconate-a clinical study	3 months

Secondary Outcome Measures

Name	Time	Method
micro-biologic analysis of Candidal species	3 months

Trial Locations

Locations (1): A.B Shetty memorial institute of dental science
🇮🇳
Kannada, KARNATAKA, India
A.B Shetty memorial institute of dental science
🇮🇳Kannada, KARNATAKA, India
Dr GOPAKUMAR NAIR MDS
Principal investigator
09845081625
gopakr_nair@yahoo.com