NCT07674888

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

June 22, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

family microbial transmissionOral microbiomePlaque recolonizationPediatric oral healthReal-time proximity trackingUltrawide Band (UWB)Oral bacterial transmissionIntergenerational pathogen transferBiofilm disruptionPeriodontal diseaseFamily-based interventionMicrobial source trackingOral Health

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

EXPERIMENTAL

The primary child participant receives professional dental plaque disruption and oral hygiene intervention. Other household members do not receive study-related treatment.

Procedure: Professional Dental Plaque Disruption

Child Plus Parents Treatment

EXPERIMENTAL

The primary child participant and both parents receive professional dental plaque disruption and oral hygiene intervention

Procedure: Professional Dental Plaque Disruption

Whole-Family Treatment

EXPERIMENTAL

All participating household members receive professional dental plaque disruption and oral hygiene intervention using a family-wide treatment approach.

Procedure: Professional Dental Plaque Disruption

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.

Child Plus Parents TreatmentChild-Only TreatmentWhole-Family Treatment

Eligibility Criteria

Age5 Years - 5 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll-Equal numbers of male and female participants will be recruited.
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Dental CariesPeriodontitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesMouth Diseases

Central Study Contacts

Khaled Altabtbaei, BDM, PhD

CONTACT

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
Model Details: Families will be randomized to one of three parallel intervention groups: (A) child-only treatment, (B) child plus parent treatment, or (C) treatment of all family members. Outcomes will be compared across groups to evaluate the effect of reducing household pathogen burden on oral microbial recolonization.
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

Locations