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Baseline Oral Health Study: UnCoVer the Connections to General Health

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ClinicalTrials.gov Identifier: NCT04954313
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diabetes Type 2 Drug: Subgingival chlorhexidine irrigation Other: Dental Supplies Other: Periodonal Treatment Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Baseline Oral Health Study: UnCoVer the Connections to General Health
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: 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.
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.

Other: Periodonal Treatment
Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP).

Active Comparator: 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 electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) 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.

Other: Periodonal Treatment
Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP).




Primary Outcome Measures :
  1. Impact of treatment on change in oral health measures [ Time Frame: 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 used as a measure of oral health and measured per sextant.

  2. Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c)) [ Time Frame: Comparing baseline (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 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)

  3. Association between changes in oral health and changes in systemic health (Flow-mediated dilation) [ Time Frame: Comparing baseline (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 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


Secondary Outcome Measures :
  1. Impact of treatment on emotional wellbeing [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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.

  2. Impact of treatment on beliefs about periodontal disease [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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.

  3. Impact of treatment on bleeding on probing [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Dichotomic response after probing the gingival sulcus.

  4. Impact of treatment on gingival index [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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

  5. Impact of treatment on clinical attachment level [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of gingival margin position related to the crown margin

  6. Impact of treatment on dental plaque index [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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

  7. Impact of treatment on flow-mediated dilation [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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 .

  8. Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts) [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of HbA1c

  9. Impact of treatment on carotid intima media thickness (IMT) [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    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.

  10. Impact of treatment on high sensitivity C-reactive protein (hs-CRP) [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of hs-CRP

  11. Impact of treatment on total cholesterol [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of total cholesterol

  12. Impact of treatment on low density lipoproteins (LDL) cholesterol [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of LDL

  13. Impact of treatment on triglycerides [ Time Frame: Comparing baseline (day 0) and T4 (day 360) ]
    Percent change of triglycerides



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in the Verily's Project Project Baseline Health Study
  • At least 18 years of age
  • 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 a history of at least one of the following indications of cardiometabolic disease:

    • Type 2 diabetes: 9% ≥ HbA1c ≥ 6.5% OR medical history of Type 2 diabetes
    • Prediabetes: 6.4% > HbA1c > 5.7% OR
    • Cardiovascular Disease (CVD):

      • A past coronary calcium score (CCS) of > 100 OR
      • Medical history of Myocardial Infarction, Coronary Artery Disease or stroke
  • Has a history of hsCRP level of > 1 mg/L
  • 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:

  • 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 Oral Health study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954313


Contacts
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Contact: Jon Shea 704-250-5044 jon_shea@unc.edu
Contact: Silvana C Barros, DDS, PhD 919-537-3166 Silvana_Barros@unc.edu

Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: Silvana Barros, DDS, PhD    919-537-3166    Silvana_Barros@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Colgate Palmolive
Investigators
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Principal Investigator: Silvana Barros, DDS, PhD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04954313    
Other Study ID Numbers: 21-1453
CRO-2020-03-VERILY-LK ( Other Identifier: Verily )
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Time Frame: 9 to 36 months following publication
Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
Oral health
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants