Obesity and Oral Diseases in Adult Patients

Sponsor
University of Bergen
Study ID
NCT04602572
Status
Not Yet Recruiting

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Conditions

  • Dental Caries
  • Dental Erosion
  • Obesity
  • Oral Diseases
  • Periodontitis

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle course. — BEHAVIORAL
    Pharmacotherapy
  • Bariatric surgery. — PROCEDURE
    Sleeve gastrectomy or gastric bypass.

Study Details

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.

Key Dates

First listed
Oct 26, 2020
Start date
Nov 1, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Non-surgical group.
    Patients will be offered a standardized program comprised of individual consultations by a trained nurse every 3 months over 2 years, participation in a lifestyle course with 13 group sessions focusing on healthy diet and physical activity, and pharmacotherapy.
  • Arm: Surgical group
    After completing the systematic work-up and the lifestyle course, eligible subjects will be offered bariatric surgery. The surgical procedure will be chosen at the surgeon's discretion taking into consideration the target weight, comorbidities, risk of complications, the patient's ability to cope with side effects and complications, and the patient's motivation.

Primary Outcome Measure

Changes in probing depth (PD) [ Time Frame: 18 months. ]

Central Contacts

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