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Obesity and Oral Diseases in Adult Patients

Study acronym: ObOd
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Dec 30, 2025 to Dec 30, 2027
    • Start date: Sep 1, 2025 to Nov 1, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v8
  2. Notable Primary completion date: Mar 30, 2025 to Dec 30, 2025
    • Start date: Aug 1, 2024 to Sep 1, 2025
    • Study completion date: Sep 3, 2025 to Dec 31, 2025
    v7
  3. Notable Primary completion date: Sep 30, 2024 to Mar 30, 2025
    • Start date: Jan 1, 2024 to Aug 1, 2024
    v6
  4. Notable Primary completion date: Mar 31, 2023 to Sep 30, 2024
    • Start date: Dec 1, 2022 to Jan 1, 2024
    • Study completion date: Mar 31, 2024 to Sep 3, 2025
    v5
  5. Notable Primary completion date: Mar 31, 2022 to Mar 31, 2023
    • Start date: Dec 1, 2021 to Dec 1, 2022
    v4
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  1. Notable Start date: Dec 1, 2020 to Dec 1, 2021v3
  2. Minor Secondary endpoints: details revised at 2 of 7 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Overweight and obesity are among the major chronic disorders of the 21st century and one of the fastest growing health problems worldwide. Obesity is accompanied by a state of low-grade inflammation which may contribute to the occurrence of diabetes mellitus, cardiovascular disease, hypertension, stroke, and certain cancers. Furthermore, obesity has been associated with oral health problems as hyposalivation, dental caries and periodontitis. The management and treatment of obesity is outlined in clinical guidelines from American Association of Clinical Endocrinologists/American College of Endocrinology and European Association for the Study of Obesity. The cornerstone is life-style modification programs aiming to reduce energy intake and increase physical activity, referred to as conservative treatment. All patients must undergo a thorough systematic work-up. The work-up concludes in a final multi-disciplinary meeting with a concrete individualized plan on how sustained weight-loss is to be achieved; either by a non-surgical or a surgical approach (Bariatric surgery). Periodontitis is cited to be the sixth most prevalent chronic condition globally. The mechanisms by which obesity affects the periodontal tissues is poorly understood, and the understanding of the key role of adipocytes in the inflammatory response to infections is crucial in comprehending how periodontal disease susceptibility may be modified in obese individuals. The main objectives of the present research project are to explore the association between obesity and oral diseases and further, to assess how weight changes following non-surgical and surgical interventions of obese patients may affect the cariological and periodontal health status. Four hundred patients referred to the Obesity Centre at Haukeland University Hospital, Norway will consecutively be screened and invited to participate in this prospective cohort study. At baseline, detailed medical and oral data will be obtained from health forms, questionnaires, clinical examinations, and by consulting the patient's care team. Following baseline examination, all patients will undergo a thorough systematic work-up consisting av interviews and consultations concluding in a final multi-disciplinary individualized non-surgical or surgical treatment plan on how sustained weight-loss can be achieved. New sets of medical, oral, and molecular data will be collected at 3-, 12- and 18-month following non-surgical/surgical interventions.
Trial Details
NCT Number NCT04602572
Lead Sponsor University of Bergen
Collaborators: Haukeland University Hospital, University of North Carolina, Chapel Hill
Conditions
(from sponsor)
Obesity, Oral Diseases, Periodontitis, Dental Caries, Dental Erosion
Related terms Dental Caries, Obesity, Overweight, Periodontitis, Tooth Erosion
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov