Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets
1 other identifier
interventional
225
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
June 30, 2026
June 1, 2026
1.5 years
June 22, 2026
June 25, 2026
Conditions
Keywords
Outcome Measures
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).
3 Months
Secondary Outcomes (3)
Oral Microbial Community Reconstitution
Baseline to 3 Months
Frequency of Close-Contact Interactions Measured using Ultrawide Band (UWB)
1 Week
Correlation Between Close-Contact Duration and Familial Contribution to Oral Microbial Recolonization
Baseline to 3 Months
Study Arms (3)
Child-Only Treatment
EXPERIMENTALThe primary child participant receives professional dental plaque disruption and oral hygiene intervention. Other household members do not receive study-related treatment.
Child Plus Parents Treatment
EXPERIMENTALThe primary child participant and both parents receive professional dental plaque disruption and oral hygiene intervention
Whole-Family Treatment
EXPERIMENTALAll participating household members receive professional dental plaque disruption and oral hygiene intervention using a family-wide treatment approach.
Interventions
Professional 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.
Eligibility Criteria
You may qualify if:
- 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.
- Ability of participants or their legal guardians to provide informed consent, and assent from children where applicable.
You may not qualify if:
- 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.
- Medical or behavioral conditions that, in the opinion of the investigators, would preclude safe participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaye Edmonton Clinic - University of Alberta School of Dentistry
Edmonton, Alberta, T6G2L7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants and investigators will know which treatment group the family has been assigned to.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
June 30, 2026
Study Start (Estimated)
September 30, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
June 30, 2026
Record last verified: 2026-06