Baseline Oral Health Study: UnCoVer the Connections to General Health
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 786
- 试验地点
- 2
- 主要终点
- Impact of Treatment on Change in Oral Health Measures
研究概览
简要总结
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health.
Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering.
Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
详细描述
The Baseline Oral Health Health Study is a randomized controlled trial to evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health. The study will be conducted in partnership with Verily and the Project Baseline Team, Colgate, and the University of North Carolina. The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app.
The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and all sub-investigators will make every effort to remain blinded as to the subject regimen. Periodontal treatment throughout the Study will be provided only by experienced general dentists, periodontists or dental hygienists who are licensed, trained and calibrated prior to the start of the study. In order to maintain examiner blinding throughout the study, the treatment provider will be a person other than the dental examiner and will exclusively provide treatment and not participate in patient assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least eighteen (18) years of age but not older than seventy (70) years of age at the time of screening
- •Able to speak and read English
- •Has at least 16 teeth present.
- •Able to consent, follow an outpatient protocol, and is available by telephone
- •Has either moderate (stage II) or severe (stage III) periodontitis:
- •Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss = 3 to 4mm with maximum probing depth ≤ 5mm
- •Stage III - Interdental CAL at the site of greatest loss ≥ 5mm, probing depth (PD)≥ 6mm, and radiographic bone loss (vertical bone loss ≥ 3mm)
- •Has at least one of the following indicators of cardiometabolic disease in the following range:
- •Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR Prediabetes: 6.4%≥ HbA1c ≥ 5.7% OR
- •Cardiovascular Disease (CVD):
- •Medical history of Myocardial Infarction, Coronary Artery Disease or stroke
- •Access to Apple (iOS) devices or Android devices with appropriate versions to be compatible with the applications to complete study procedures.
- •Females of childbearing capacity must be willing to have pregnancy test
排除标准
- •Individuals who exhibit gross oral pathology
- •Presenting oral manifestations of systemic diseases (e.g. pemphigus, pemphigoid, lupus)
- •Presence of any acute or chronic systemic infection as determined by the clinician
- •Periodontal treatment performed within 6 months prior to study start
- •Refusal to extract hopeless teeth identified as determined by the clinician at the screening visit.
- •Participating in any other interventional cardiometabolic or Oral Health study
- •Individuals currently undergoing any type of orthodontic treatment (e.g. aligners)
研究组 & 干预措施
Treatment Group
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
干预措施: Subgingival chlorhexidine irrigation (Drug)
Treatment Group
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
干预措施: Dental Supplies (Other)
Treatment Group
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS & PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
干预措施: Periodonal Treatment (Other)
Control Group
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
干预措施: Periodonal Treatment (Other)
结局指标
主要结局
Impact of Treatment on Change in Oral Health Measures
时间窗: Comparing T1 (day 90) and T4 (day 360)
The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.
Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)
时间窗: Comparing T0 (day 0) and T4 (day 360)
The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening.
Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)
时间窗: Comparing T0 (day 0) and T4 (day 360)
The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated.
次要结局
- Change in Emotional Wellbeing(Comparing T0 (day 0) and T4 (day 360))
- Change in Beliefs About Periodontal Disease(Comparing T0 (day 0) and T4 (day 360))
- Change in Bleeding on Probing(Comparing T0 (day 0) and T4 (day 360))
- Change in Gingival Index(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Clinical Attachment Level (CAL)(Comparing T0 (day 0) and T4 (day 360))
- Change in Dental Plaque Index(Comparing T0 (day 0) and T4 (day 360))
- Change in Flow-mediated Dilation(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Carotid Intima Media Thickness (IMT)(Comparing T0 (day 0) and T4 (day 360))
- Percent Change of High Sensitivity C-reactive Protein (Hs-CRP)(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Total Cholesterol(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Low Density Lipoprotein (LDL) Cholesterol(Comparing T0 (day 0) and T4 (day 360))
- Percent Change in Triglycerides(Comparing T0 (day 0) and T4 (day 360))