Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-5
SponsorUniversity of Alberta
About this trial
This study aims to understand how oral bacteria that cause tooth decay and gum disease spread among family members and whether treating multiple family members can reduce the return of these bacteria after dental treatment.
Families with children aged 5-12 years will be recruited from university dental clinics. Participants will be assigned to one of three treatment groups: treatment for the child only, treatment for the child and parents, or treatment for all family members. Researchers will collect oral bacterial samples from family members before and after treatment and will monitor close-contact interactions within the household using wearable proximity-tracking devices.
The study will also collect information about oral health habits, family interactions, and environmental factors that may influence bacterial transmission. By combining bacterial DNA analysis with information about family contact patterns, researchers hope to better understand how oral bacteria are shared within households and whether family-based treatment approaches can reduce bacterial recolonization after dental therapy.
The results of this study may help improve strategies for preventing childhood tooth decay and gum disease by addressing family-level sources of bacterial transmission.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Families with at least two children aged 5-12 years living in the same household.
least one parent or guardian diagnosed with Stage II or III periodontitis requiring non-surgical periodontal therapy.
At least one child who has undergone caries treatment and is considered at high risk for disease recurrence.
Willingness of all participating household members to provide oral samples and participate in study procedures.
Disqualifiers
Children living in multiple households or shared-custody arrangements during the study period.
Households unable to complete study visits or follow-up procedures.
Individuals unwilling or unable to comply with study procedures.
Individuals who do not provide informed consent or assent, where applicable.
Trial design
Design model
Parallel
Treatments tested in this trial
Professional Dental Plaque Disruption
Procedure/SurgeryProfessional dental plaque disruption and oral hygiene treatment performed to reduce oral bacterial burden. The intervention may include professional dental cleaning, plaque removal, and periodontal therapy as clinically indicated according to study group assignment.
Treatment groups
225 Participants
are divided into 3 treatment groupsGroup A: Child-Only TreatmentExperimental treatment 1 intervention
Group B: Child Plus Parents TreatmentExperimental treatment 1 intervention
Group C: Whole-Family TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportional Contribution of Familial Sources to Oral Microbial Recolonization
Percentage contribution (%) of each household member to the primary child's post-treatment oral microbial recolonization, estimated using bacterial DNA sequencing and Bayesian microbial source-tracking (STENSL).
Time frame
3 MonthsSecondary outcomes
1
Oral Microbial Community Reconstitution
Oral microbial community reconstitution assessed by relative abundance (%) of oral bacterial taxa and microbial alpha diversity of the oral microbiota, measured using 16S rRNA gene sequencing.
Time frame
Baseline to 3 Months2
Frequency of Close-Contact Interactions Measured using Ultrawide Band (UWB)
Number of close-contact interactions (count) between household members measured using wearable Ultrawide Band (UWB) proximity sensors.
Time frame
1 Week3
Correlation Between Close-Contact Duration and Familial Contribution to Oral Microbial Recolonization
Correlation between cumulative close-contact duration (minutes), measured using wearable Ultrawide Band (UWB) proximity sensors, and the proportional contribution (%) of each family member to the primary child's oral microbial recolonization, estimated from bacterial DNA sequencing data using the Bayesian microbial source-tracking algorithm (STENSL).
Time frame
Baseline to 3 MonthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: