Dental CariesNCT07674888
Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets
A study testing Professional Dental Plaque Disruption in people with Dental Caries and Periodontitis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Periodontitis, Oral Microbiome
- What is being tested?
- Professional Dental Plaque Disruption
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kaye Edmonton Clinic - University of Alberta School of Dentistry
Edmonton, Alberta, T6G2L7
Khaled Altabtbaei, BDM, PhD, 780-777-2456, altabtba@ualberta.ca
About this study
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.
Read more
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.
- Conditions
- Dental Caries, Periodontitis, Oral Microbiome, Bacterial Transmission
- Being tested
- Professional Dental Plaque Disruption
- 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
- Medical subject headings
- Dental Caries, Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional Dental Plaque DisruptionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Procedure: Professional Dental Plaque Disruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 Months
Secondary outcomes (3)
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.
Measured: Baseline to 3 Months
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.
Measured: 1 Week
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).
Measured: Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674888
- Sponsor's protocol ID
- Pro00164902
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets
- ClinicalTrials.gov ID
- NCT07674888
- Acronym / sponsor ID
- Pro00164902
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Child-Only Treatment | Experimental | Procedure: Professional Dental Plaque DisruptionThe 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 | Experimental | Procedure: Professional Dental Plaque DisruptionThe primary child participant and both parents receive professional dental plaque disruption and oral hygiene intervention |
| Whole-Family Treatment | Experimental | Procedure: Professional Dental Plaque DisruptionAll participating household members receive professional dental plaque disruption and oral hygiene intervention using a family-wide treatment approach. |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional Dental Plaque DisruptionProfessional 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. | Procedure or surgery | Child Plus Parents Treatment, Child-Only Treatment, Whole-Family Treatment |
Primary outcome
Proportional Contribution of Familial Sources to Oral Microbial Recolonization
Time frame: 3 Months
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 secondary outcomes
Oral Microbial Community Reconstitution
Time frame: Baseline to 3 Months
Frequency of Close-Contact Interactions Measured using Ultrawide Band (UWB)
Time frame: 1 Week
Correlation Between Close-Contact Duration and Familial Contribution to Oral Microbial Recolonization
Time frame: Baseline to 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional Dental Plaque Disruption in people with Dental Caries and Periodontitis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Altabtbaei, BDM, PhD (780-777-2456, altabtba@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportional Contribution of Familial Sources to Oral Microbial Recolonization (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.