Loading search results

Outcome Measures

Primary Outcomes (3)

Oral Health Status
Oral Hygiene Index-Simplified (OHI-S) score
6 months
Gingival Health Status
Modified Gingival Index (MGI) score
6 months
Oral Health Related Quality of Life (OHRQoL)
Child Perception Questionnaire for varying ages 8 to 10 and 11 to 14 and upward (CPQ8-10, CPQ11-14)
6 months

Secondary Outcomes (5)

Study Arms (2)

Education intervention (Oral health education and instructions/training for self-oral care)

EXPERIMENTAL

The intervention arm will be given a 45 minute oral health education which will include oral hygiene instructions and motivation/training for oral self-care (dietary counselling; snacking during and not mealtimes; post-meal rinsing; flossing; brushing frequency, time, and method; tongue cleaning; toothbrush type/care; toothpaste quantity/type; dental visits). Audio-visual aids and leaflets reinforcing the oral health education will also be provided.

Other: Oral health education and instructions/training for self-oral care

No intervention (Control)

NO INTERVENTION

The control arm/group will receive no intervention (Oral health education) until right after the study is over.

Eligibility Criteria

Age8 Years - 16 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

HIV-infected children aged 8-16 years (who can self-implement the oral health intervention with minimal caregiver supervision) attending selected clinics. HIV status will be based on clinic records.
Primary caregiver consent; assent from child.

Related Publications (1)

Adeyemo YI, Aliyu MH, Folayan MO, Coker MO, Riedy CA, Maiyaki BM, Denloye OO. A 2-arm randomized controlled study to improve the oral health of children living with HIV in Nigeria: Protocol and study design. Contemp Clin Trials. 2024 Jan;136:107375. doi: 10.1016/j.cct.2023.107375. Epub 2023 Oct 30.

PMID: 38404532DERIVED

MeSH Terms

Conditions

Dental CariesMouth DiseasesOral Manifestations

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth Services

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, OUTCOMES ASSESSOR

Masking Details

The research assistants (dentists) collecting data and the study statistician will be blinded as to which sites are the intervention and control arms. The primary investigator and instructor will not be blinded as knowledge of the intervention will be necessary to ensure proper implementation of the intervention protocol.

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: A 2-arm randomized control study which involves two groups of participants who will be recruited into the study at the sites. The sites would have been randomized into control and intervention arms using a simple lottery technique. Four (4) identical slips of paper with 'control' printed on 2 on them and 'intervention' on the other 2 slips will be provided. Each paper will be sealed in envelopes which will all be identical, and they will be placed in a box. An individual unconnected to the study will be asked to select two (2) envelopes from the box and these will be assigned the control group while the two (2) envelopes left in the box will be the assigned the intervention group.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Dr.

An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

Education intervention (Oral health education and instructions/training for self-oral care)

No intervention (Control)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (2)

Education intervention (Oral health education and instructions/training for self-oral care)

No intervention (Control)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations