Obesity Clinical Trial
— ObOdOfficial title:
Obesity and Oral Diseases in Adult Patients
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | September 3, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - Obese adult patients. - Patients referred to the Obesity Clinic at the Hospital. Exclusion Criteria: - Unwillingness to participate. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Bergen | Haukeland University Hospital, University of North Carolina, Chapel Hill |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in probing depth (PD) | PD: The vertical distance from the gingival margin to the probable base of the pocket in mm. | 18 months. | |
Primary | Change in clinical attachment level (CAL) | CAL: The vertical distance from the cemento-enamel junction or the margin of a dental restoration to the probable base of the pocket in mm. | 18 months. | |
Secondary | Bleeding on probing (BoP). | At site level, BoP will be recorded as present upon gentle probing to the base of the pocket. | 18 months. | |
Secondary | Gingival crevicular fluid (GCF). | Sites will be isolated with cottons rolls, cleaned for supragingival plaque, and air-dried. A perio paper strip will then be placed 1-2 mm into the orifice of the site and left in place for 30 sec. The perio strip will be inserted into the Periotron 8000® (Oraflow, Smithtown, NY, USA) calibrated to estimate the volume of GCF collected. | 18 months. | |
Secondary | Unstimulated saliva. | Salivary collection will be performed directly into a sterile tube (Epperdorf North America, Hauppauge, NY). | 18 months. | |
Secondary | Whole blood | A volume of 5 ml peripheral blood will be obtained from each patient by venipuncture in the antecubital fossa following an overnight fast. | 18 months. | |
Secondary | Tooth loss | The number of missing teeth will be counted at baseline and after 18 months observation. | 18 months | |
Secondary | Dental caries | Caries will be quantitatively scored according to Espelid & Tveits clinical index based on six (6) grades (0-5) where 0 indicates no caries and 5 deep caries into the inner third of dentin. Caries will be scored at baseline and at 18 months. | 18 months | |
Secondary | Dental erosion | Dental erosion will be quantitatively scored according to the VEDE clinical index system based on six (6) grades (0-5) where 0 indicates no erosion and 5 > 2/3 of the surface exposed. Dental erosion will be scored at baseline and at 18 months. | 18 months |
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