CTRI Number |
CTRI/2011/12/002212 [Registered on: 08/12/2011] Trial Registered Retrospectively |
Last Modified On: |
07/12/2011 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Preventive Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Prevention and Treatment of Oral Candidiasis Among Pediatric HIV Patients |
Scientific Title of Study
|
Treatment of Oral Candidiasis by chlorhexidine gluconate oral rinse. a clinical study Among Pediatric HIV Patients. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Karthik Hegde |
Designation |
Senior Lecturer |
Affiliation |
peoples college of research center |
Address |
Department of Oral Medicine and Radiology, peoples college of research center, bhanpur, bhopal. peoples college of research center, bhanpur, bhopal. Bhopal MADHYA PRADESH 462037 India |
Phone |
9009990408 |
Fax |
|
Email |
hegdekarthik28@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gopakumar R |
Designation |
Proffessor and HOD |
Affiliation |
Mahatma Gandhi Dental College and Hospital, jaipur |
Address |
Department of Oral Medicine and Radiology, Mahatma Gandhi Dental College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road Jaipur, Rajasthan, India Department of Oral Medicine and Radiology, Mahatma Gandhi Dental College and Hospital, RIICO Institutional Area, Sitapura, Tonk Road Jaipur, Rajasthan, India Jaipur RAJASTHAN 302022 India |
Phone |
09845081625 |
Fax |
|
Email |
gopakr_nair@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Karthik Hegde |
Designation |
Senior Lecturer |
Affiliation |
peoples college of research center |
Address |
Department of Oral Medicine and Radiology, peoples college of research center, bhanpur, bhopal. peoples college of research center, bhanpur, bhopal. Bhopal MADHYA PRADESH 462037 India |
Phone |
9009990408 |
Fax |
|
Email |
hegdekarthik28@yahoo.com |
|
Source of Monetary or Material Support
|
AB shetty memorial institute of dental sciences, mangalore |
|
Primary Sponsor
|
Name |
AB Shetty memorial institute of dental science mangalore |
Address |
AB Shetty memorial institute of dental science, nityananda nagar, mangalore |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr GOPAKUMAR NAIR MDS |
A.B Shetty memorial institute of dental science |
Department of Oral Medicine and Radiology,A.B Shetty memorial institute of dental science, mangalore Dakshina Kannada KARNATAKA |
09845081625
gopakr_nair@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical committee,AB Shetty memorial institute of dental science, mangalore |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
HIV positive pediatric patients, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Chlorhexidine gluconate |
5 ml mouth rinse,0.12%, once daily for three months. periogaurd 0.12% |
Intervention |
Chlorhexidine gluconate |
5 ml mouth rinse,0.12%, twice daily for three months. periogaurd 0.12% |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
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
|
|
ExclusionCriteria |
Details |
1.On systemic medication.
2.CFU less than 5.
3.Any other type of candidiasis. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
prevention and treatment of oral candidiasis among pediatric HIV positive patients using chlorhexidine gluconate-a clinical study |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
micro-biologic analysis of Candidal species |
3 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
15/11/2007 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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 the
CFU analyses. After 90 days of CHX oral rinse therapy, 21 Subjects achieved
complete elimination of CFU at the end of 90 days. In 18 subjects candida
albicans were undetectable at the end of 90 days and 4 subjects had 10 fold
reduction in the colonies after 90 days, though a complete elimination was not
possible among them.
|