ClinicalTrials.gg
Not yet recruitingNCT07674888Updated Jun 30, 2026

Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets

An interventional study of Professional Dental Plaque Disruption in Dental Caries, Periodontitis and Oral Microbiome, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged 5 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by University of Alberta · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
5 Years to 5 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Dental Caries with a site in Canada — 2 open to participants now, 2 under way, none of them phase 3. Dental Caries · Canada.

Planned enrollment
5th of 11
225 · median 180
Started
2026
the only one that year
No phase
6 of 13
1 open now
Registered
13th of 13
by date
Lead sponsor
1 of 13
University of Alberta

Among the 13 studies in Dental Caries with a site in Canada, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 6 with no phase, and was the 13th registered.

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

Browse Dental Caries studies →

Open to participants now

2 of the 13 studies in Dental Caries with a site in Canada are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.

This study: 5 Years to 5 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

Oral diseases, including dental caries and periodontal diseases, are among the most prevalent chronic diseases worldwide. Although oral pathogens are known to be transmissible, the mechanisms by which disease-associated bacteria spread within families and contribute to recolonization after treatment remain poorly understood.

This randomized clinical trial will investigate familial oral microbial transmission and the role of household-level interventions in modifying microbial recolonization following professional dental therapy. Forty-five families will be recruited from university dental clinics and randomized into one of three intervention groups: (A) child-only plaque disruption, (B) child plus parent plaque disruption, or (C) plaque disruption for all family members. Eligible households must include at least two children aged 5-12 years and at least one adult requiring periodontal therapy or a child at high risk of disease recurrence.

Oral microbial samples will be collected from all participating family members at multiple oral sites, including saliva, buccal mucosa, tongue, supragingival plaque, and subgingival plaque. Follow-up sampling will occur at 1 week, 4-6 weeks, and 3 months after treatment. Participants will complete oral health and demographic questionnaires, and all family members will wear Ultrawide Band (UWB) proximity-tracking devices to quantify real-time interpersonal contact patterns within the household. Airborne microbial sampling will also be performed to investigate potential aerosol-mediated transmission pathways.

Bacterial DNA sequencing, source-tracking algorithms, and quantitative PCR analyses will be used to identify sources of microbial recolonization and quantify transmission among family members. Generalized Linear Mixed Models will be used to examine associations between microbial transmission, proximity measures, demographic variables, and household characteristics.

The primary objective is to determine whether reducing familial pathogen burden through household-level treatment decreases recolonization of oral pathogens following dental therapy. Secondary objectives include characterizing contact-dependent and airborne transmission pathways and identifying factors associated with oral microbial transmission within families.

03

Conditions studied

  • Dental Caries
  • Periodontitis
  • Oral Microbiome
  • Bacterial Transmission

Keywords

  • family microbial transmission
  • Oral microbiome
  • Plaque recolonization
  • Pediatric oral health
  • Real-time proximity tracking
  • Ultrawide Band (UWB)
  • Oral bacterial transmission
  • Intergenerational pathogen transfer
  • Biofilm disruption
  • Periodontal disease
  • Family-based intervention
  • Microbial source tracking
  • Oral Health
04

Who can participate

Ages eligible
5 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , and assent from children where applicable.

Exclusion criteria

Exclusion Criteria:

  • 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 or assent, where applicable.
  • Medical or behavioral conditions that, in the opinion of the investigators, would preclude safe participation in the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (estimated)

Study arms

  • Experimental
    Child-Only Treatment

    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

  • Experimental
    Child Plus Parents Treatment

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

    Procedure: Professional Dental Plaque Disruption

  • Experimental
    Whole-Family Treatment

    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

  • ProcedureProfessional Dental Plaque Disruption

    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.

06

What researchers measure

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 Months

Secondary 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 Months

  2. 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 Week

  3. 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 Months

07

Study locations

1 site
  • Kaye Edmonton Clinic - University of Alberta School of Dentistry
    Edmonton, Alberta T6G2L7, Canada
08

References and documents

Individual participant data

Plan to share: Undecided — A decision regarding sharing of individual participant data (IPD) has not yet been made. Data sharing plans will be determined in accordance with University of Alberta policies, participant consent, and applicable ethics requirements.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.

Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 18 months is above that.

Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2026
First posted
Jun 30, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Jun 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07674888
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jun 30, 2026

Study contacts

Khaled Altabtbaei, BDM, PhD
Contact
altabtba@ualberta.ca
780-777-2456

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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