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CTRI Number  CTRI/2020/03/024363 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 07/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Action of teeth treatment on fungal growth in mouth of HIV infected children under HIV treatment. 
Scientific Title of Study   Effect of dental treatment on oral health-related quality of life and Candida albicans carriage in HIV infected children under antiretroviral therapy – a longitudinal study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monica Gurupriya M 
Designation  PG student 
Affiliation  Ragas dental college and hospital 
Address  Department - Public Health Dentistry Ragas dental college.

Chennai
TAMIL NADU
600060
India 
Phone  09600047692  
Fax    
Email  gurupriya.monica@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Monica Gurupriya M 
Designation  PG student 
Affiliation  Ragas dental college and hospital 
Address  Department- Public health dentistry

Chennai
TAMIL NADU
600060
India 
Phone  09600047692  
Fax    
Email  gurupriya.monica@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Monica Gurupriya M 
Designation  PG student 
Affiliation  Ragas dental college and hospital 
Address  Department- Public health dentistry

Chennai
TAMIL NADU
600060
India 
Phone  09600047692  
Fax    
Email  gurupriya.monica@gmail.com  
 
Source of Monetary or Material Support  
Dr.Monica gurupriya M Ragas dental college,Chennai  
 
Primary Sponsor  
Name  Monica Gurupriya M 
Address  Ragas dental college 
Type of Sponsor  Other [Self sponsor] 
 
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 
Mr Joseph  Home for needs,Thiruvallur  No.21, J.N.Road (Opposite to Government hospital,Thiruvallur)
Thiruvallur
TAMIL NADU 
9944478745

joseph_s@wvi.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,Ragas dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children with well-controlled HIV infection (Under HAART with CD4 count >200cell/mm 3) for the past 1 year.
2. Children who agreed to participate, and whose parents / guardian give consent. Consent was also obtained from the Head of the Institution.
3.Children with 1 or more carious teeth.

 
 
ExclusionCriteria 
Details  1.Children who gave history of prolonged antibiotic treatment.
2.Children with fungal infection in the mouth / under antifungal therapy.
3.Children with chronic diseases, such as diabetes and allergies.
4.Children with any developmental anomalies of teeth.
5..Patients who were psychologically compromised(mental retardation , etc.)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post dental treatment-Oral health related quality of life.  Baseline,4weeks after dental treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Post dental treatment Candida albicans count.  4months(April-july) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2020 
Date of Study Completion (India) 01/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Previously did a prevalence study on alexithymia among HIV infected children. (Gurupriya MM, Iyer K, Kumar PD. Prevalence of alexithymia among a cohort of well-controlled HIV-infected adolescents and non-HIV-infected adolescents. J Global Oral Health 2019;2(1):3-8. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Thirty children from the Home for needs (Tiruvallur) who fit with inclusion criteria and are willing to participate, shall be enrolled. The children will be introduced and subjected to OHIP-14 questionnaire to assess their oral health related quality of life(OHRQoL) and baseline oral swab will be collected to assess the Candida albicans carriage in the oral cavity. Swab sample will be taken by rolling the sterile cotton swab across the dorsum of the tongue, vestibular sulcus and peak of the palatal vault. Swab sample will be immediately smeared onto the surface of culture plate with Sabouraud’s dextrose agar(100gm)(with chloramphenicol 10%). The collected swabs will be transported in cold chain maintained at 4 degree C within 2hours from the time of collection. Plates will be aerobically incubated at 37° centigrade for 48 to 72 hours. Number of Candida colonies will be determined by counting Colony Forming Units on Sabouraud’s dextrose agar plates. Preliminary identification of Candida will be carried out after the growth of characteristic creamy convex yeast colonies on SDA. All the microbiological analysis will be done at Standard Healthcare Multi-Speciality clinic and Diagnostic Centre  at Pallikaranai, Chennai. This will be followed by dental treatment such as restoration and extraction. Oral hygiene kit will be provided commonly to all the participants to maintain homogeneity in oral care. Daily reminders about oral hygiene will be given through phone calls to all participants. Four weeks after finishing the dental treatment, another oral swab sample will be  collected from the patients according to the criteria described previously. Post-treatment OHIP-14 questionnaire will be administered finally.

 


 
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