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
|
|
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
|
|
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. |