Breaking the Cycle: Real-Time Family Oral Microbial Transmission Patterns as Intervention Targets
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Khaled Altabtbaei, BDM, PhD
- Telefonní číslo: 780-777-2456
- E-mail: altabtba@ualberta.ca
Studijní místa
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G2L7
- Kaye Edmonton Clinic - University of Alberta School of Dentistry
-
Kontakt:
- Khaled Altabtbaei, BDM, PhD
- Telefonní číslo: 780-777-2456
- E-mail: altabtba@ualberta.ca
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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 informed consent, and assent from children where applicable.
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 informed consent or assent, where applicable.
- Medical or behavioral conditions that, in the opinion of the investigators, would preclude safe participation in the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Experimentální: Child Plus Parents Treatment
The primary child participant and both parents receive professional dental plaque disruption and oral hygiene intervention
|
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.
|
|
Experimentální: Whole-Family Treatment
All participating household members receive professional dental plaque disruption and oral hygiene intervention using a family-wide treatment approach.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportional Contribution of Familial Sources to Oral Microbial Recolonization
Časové okno: 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 Months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oral Microbial Community Reconstitution
Časové okno: Baseline to 3 Months
|
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.
|
Baseline to 3 Months
|
|
Frequency of Close-Contact Interactions Measured using Ultrawide Band (UWB)
Časové okno: 1 Week
|
Number of close-contact interactions (count) between household members measured using wearable Ultrawide Band (UWB) proximity sensors.
|
1 Week
|
|
Correlation Between Close-Contact Duration and Familial Contribution to Oral Microbial Recolonization
Časové okno: Baseline to 3 Months
|
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).
|
Baseline to 3 Months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- Orální zdraví
- Parodontální onemocnění
- Orální mikrobiom
- Rodinná intervence
- Pediatrické zdraví ústní dutiny
- family microbial transmission
- Plaque recolonization
- Real-time proximity tracking
- Ultrawide Band (UWB)
- Oral bacterial transmission
- Intergenerational pathogen transfer
- Biofilm disruption
- Microbial source tracking
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00164902
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .