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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Khaled Altabtbaei, BDM, PhD
- 電話番号：780-777-2456
- メール：altabtba@ualberta.ca
研究場所
-
-
Alberta
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Edmonton、Alberta、カナダ、T6G2L7
- Kaye Edmonton Clinic - University of Alberta School of Dentistry
-
コンタクト：
- Khaled Altabtbaei, BDM, PhD
- 電話番号：780-777-2456
- メール：altabtba@ualberta.ca
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportional Contribution of Familial Sources to Oral Microbial Recolonization
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oral Microbial Community Reconstitution
時間枠：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.
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Baseline to 3 Months
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Frequency of Close-Contact Interactions Measured using Ultrawide Band (UWB)
時間枠：1 Week
|
Number of close-contact interactions (count) between household members measured using wearable Ultrawide Band (UWB) proximity sensors.
|
1 Week
|
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Correlation Between Close-Contact Duration and Familial Contribution to Oral Microbial Recolonization
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Pro00164902
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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