Baseline Oral Health Study: UnCoVer the Connections to General Health

Cardiovascular Diseases Clinical Trial

Official title:

Baseline Oral Health Study: UnCoVer the Connections to General Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04954313
• Other study ID #: 21-1453
• Secondary ID: CRO-2020-03-VERI
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 28, 2021
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Subgingival chlorhexidine irrigation
The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).

Other:
• Dental Supplies
Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
• Periodonal Treatment
Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP).

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	UNC Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of treatment on change in oral health measures	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 used as a measure of oral health and measured per sextant.	Comparing T1 (day 90) and T4 (day 360)
Primary	Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c))	The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths will be used as a measure of oral health and measured per sextant. The strength of correlations between changes in oral health and change in HbA1c (in subjects with prediabetes or type 2 diabetes)	Comparing baseline (day 0) and T4 (day 360)
Primary	Association between changes in oral health and changes in systemic health (Flow-mediated dilation)	The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths will be used as a measure of oral health and measured per sextant. The strength of correlations between changes in oral health and change in flow-mediated dilation	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on emotional wellbeing	Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale.	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on beliefs about periodontal disease	Emotional wellbeing will be evaluated through the use of PMT (Protective Motivation Theory questionnaire). The PMT is a total of 7 questions about opinions related to periodontal disease and treatment from 1 to 10 with 1 being not at all and 10 being extremely so.	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on bleeding on probing	Dichotomic response after probing the gingival sulcus.	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on gingival index	The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on clinical attachment level	Percent change of gingival margin position related to the crown margin	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on dental plaque index	Percent change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on flow-mediated dilation	Percent change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline. Peak hyperemic flow will be expressed as the time-velocity integral of the Doppler velocity .	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts)	Percent change of HbA1c	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on carotid intima media thickness (IMT)	Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions.	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on high sensitivity C-reactive protein (hs-CRP)	Percent change of hs-CRP	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on total cholesterol	Percent change of total cholesterol	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on low density lipoproteins (LDL) cholesterol	Percent change of LDL	Comparing baseline (day 0) and T4 (day 360)
Secondary	Impact of treatment on triglycerides	Percent change of triglycerides	Comparing baseline (day 0) and T4 (day 360)