Clinical trial NCT06081868: RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
Official title: A Randomized Clinical Trial on the Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Dental Plaque
Dental Diseases
Dental Caries in Children
Oral Disease
Oral Manifestations
Keywords: Oral health
Prevention programme
Randomized controlled trial
Sustainable healthy habits
Uganda
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 610
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dental caries represents a challenge for Oral Health Services in several African Countries, like Uganda. Few studies have been reported the burden of oral health, its prevention and non-operative treatment among school children in African countries.

Aim: To assess the prevalence and risk factors of dental caries and the effectiveness of strategies to prevent and treat dental caries using a non-operative approach among children in Gulu Municipality, Uganda.

Methods: The proposal RCT is structured in three phases: 1. A descriptive cross-sectional survey to collect oral data among 610 school children selected using a multistage cluster sampling; 2. A randomized unblinded two-arm trial to assess the difference in the treatment/prevention of dental caries using non-operative means among school children in the Ugandian Gulu municipality; and 3. A comparison of oral health conditions between a group of children who will be given dental cleaning tools and followed up over time versus a control group.

The oral health status of the participants will be assessed according to WHO and ICDAS guidelines. Stata 14.0. will be used for analysis; descriptive statistics will be carried out to analyze continuous and categorical variables and chi-square test as well as independent tests for bivariate analysis and modified poisson regression. In addition, the factors associated with dental caries will be determined by linear regression models using a statistical significance level of 5% (α = 0.05).

Discussion: This trial will be the first trial conducted in Uganda assessing a school-based caries prevention programme using the WHO and ICDAS standardized international guidelines. The findings obtained will increase knowledge on oral health in Uganda school children and the effectiveness of community-based caries prevention programme in this population.

Detailed description: Study design

This randomized controlled clinical study will be developed in three parts: 1.) An epidemiological survey; a descriptive cross-sectional study to be conducted in Gulu Municipality to collect data on the oral health of school children to assess caries prevalence and associated factors. 2.) A field trial; an individually randomized, unblinded, two-armed trial of toothbrush/toothpaste/fluoride varnish versus education on nutrition/oral hygiene to assess the difference in treatment/prevention of dental caries. 3.) A comparison of oral health conditions among a group of children who were provided with dental cleaning tools and who were followed up and monitored over time versus a control group.

Study setting and location

The study will be conducted in Gulu Municipality, Gulu District, in Northern Uganda. The municipality has four sub-counties, each consisting of four parishes, with a total population of 177'400 according to the Uganda Bureau of Statistics (UBOS), 2020 projection \[Uganda Bureau of Statistics in Uganda. April 2019 Population Projections by Subcounty and Sex (2015-2030), in Population \& Censuses. 2019\]. It is the largest urban center in Acholi sub-region. There are three hospitals offering oral health services in Gulu Municipality: Gulu referral hospital, St. Mary's Hospital, Lacor and Gulu independent hospital. Primary schools in Gulu Municipality will be used as study areas. The list of primary schools in the Municipality will be obtained from the District Education Officer (DEO). An ethical approval from the Ministry of Health and consents from parents of the school children will be required.

Study population

The study will be conducted among school children in Gulu Municipality for 24 months, starting in September 2024. The inclusion criteria will be: enrollment in one of primary schools in Gulu Municipality, age between 5 and 17 years, staying in the area for at least six months and parent/guardian's willingness to give consent. Exclusion criteria will be: school children who refuse to participate in the research and/or parents who refuse their children's participation and children with chronic diseases or systemic conditions that require differential care and follow-up.

Data collection

A modified World Health Organization (WHO) questionnaire on children oral health \[Oral health surveys: basic methods. 2013: World Health Organization.\] will be used for each participant to identify factors such as socioeconomic status, dietary habits, oral health habits, and dental attendance associated with oral health data.

The dental examinations will be performed by five trained and calibrated dentists. These will receive an intensive two-day training session of at least 72 hours together with a demonstration on images depicting carious lesions of varying severity in order to learn how to assess them through the International Caries Detection and Assessment System \[Dikmen, B., ICDAS II criteria (International Caries Detection and Assessment System). Journal of Istanbul University Faculty of Dentistry, 2015;49(3):63.\].

A benchmark examiner will calibrate the examiners' practice on caries detection to ensure accurate and correct application of the research procedures. The first ten enrolled participants will be used for calibration exercise. The unweighted kappa statistic will be used to assess the inter-examiner and intra-examiner agreement. The dental examination will be carried out using a mirror and a probe, under appropriate artificial light and after cleaning the teeth with cotton rolls to remove food debris and dental plaque. Oral health status will be evaluated according to the method and criteria recommended by the WHO \[Oral health surveys: basic methods. 2013: World Health Organization.\], including the ICDAS \[Dikmen, B., ICDAS II criteria (International Caries Detection and Assessment System). Journal of Istanbul University Faculty of Dentistry, 2015;49(3):63.\].

The following data will be collected after obtaining consent and enrolment:

* Date of enrolment
* Date and time of consent
* Participant identifiers
* Socio-economic and demographic information
* Status of the oral health

Follow up visits:

* All participants will be re-assessed clinically every three months after enrolment until the 24th month to evaluate oral health status. A symptom checklist, targeted dental examinations and a record of the findings and treatments administered will be performed at each visit.
* All costs related to the health care of the project participants will be recorded, starting from enrolment and for the duration of follow-up. The costs will also include those for any hospitalisation related to dental caries and those arising from the use of other health care resources, including the costs of materials used for each visit.

Project variables

The first part of this project is an epidemiological survey in which the prevalence of dental caries will be the primary outcome. The outcome will be calculated by determining the percentage of participants diagnosed with dental caries, while the secondary outcome will be the extent of other oral diseases. The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated. A questionnaire will be used to investigate the relationships between the prevalence of dental caries and other variables such as sex, demographic information, school, age, hygiene habits (brushing frequency), maternal education, dietary habits (frequency of mealtimes, frequency of sugar intake, sugar intake between meals, soft drink consumption between meals).

The second phase of the project is a field trial in which the outcome variable will be the presence of dental caries after the intervention. Secondary outcomes will include resolution of dental caries symptoms, cost of interventions performed.

A full study protocol will be published in a peer-reviewed journal in a timely manner and will be included here afterwards.

Eligibility criteria: Inclusion Criteria:

* Enrollment in one of primary schools in Gulu Municipality
* Age between 5 and 17 years
* Staying in the area for at least six months
* Parent/guardian's willingness to give consent
* Written informed consent by participant and/or parents

Exclusion Criteria:

* School children who refuse to participate in the research
* Parents who refuse their children's participation
* Children with chronic diseases or systemic conditions that require differential care and follow-up

Primary outcomes:
measure: Prevalence of dental caries
timeFrame: Baseline
measure: Prevalence of dental caries
timeFrame: 12 months
measure: Prevalence of dental caries
timeFrame: 24 months
measure: Mean of dental caries
timeFrame: Baseline
measure: Mean of dental caries
timeFrame: 12 months
measure: Mean of dental caries
timeFrame: 24 months
measure: Presence of dental caries after the intervention
timeFrame: Baseline
measure: Presence of dental caries after the intervention
timeFrame: 12 months
measure: Presence of dental caries after the intervention
timeFrame: 24 months
Secondary outcomes:
measure: Extent of other oral diseases
timeFrame: Baseline
measure: Extent of other oral diseases
timeFrame: 12 months
measure: Extent of other oral diseases
timeFrame: 24 months
measure: Cost of clinical interventions
timeFrame: Baseline
measure: Cost of clinical interventions
timeFrame: 12 months
measure: Cost of clinical interventions
timeFrame: 24 months
measure: Identification of dental caries symptoms
timeFrame: Baseline
measure: Identification of dental caries symptoms
timeFrame: 12 months
measure: Identification of dental caries symptoms
timeFrame: 24 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern, Switzerland
name: Thomas G Wolf, DDS,MA,Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniersity of Bern, Switzerland
name: Guglielmo Campus, DDS,PhD,Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern, Switzerland
name: Obaida El-Modalal, DDS
role: STUDY_DIRECTOR
affiliation: University of Milan, Italy
name: Maria-Grazia Cagetti, DDS,PhD,Prof
role: STUDY_DIRECTOR
affiliation: Uganda Dental Association, Uganda
name: Hannington Baliddawa, DDS, Dr.
role: STUDY_DIRECTOR
affiliation: Corti Foundation, Uganda
name: Dominique Corti, MD, Dr.
role: STUDY_DIRECTOR
affiliation: Academy of Dentistry International, USA
name: Friedrich Herbst
role: STUDY_DIRECTOR
affiliation: University of Bern, Switzerland
name: Philippe Rusca, DDS, Dr.
role: STUDY_DIRECTOR
References: