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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.



 
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