Obesity and Oral Diseases in Adult Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorUniversity of Bergen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Obese adult patients.

Patients referred to the Obesity Clinic at the Hospital.

Disqualifiers

Unwillingness to participate.

Trial population

Obese adults referred to the Obesity Centre from primary, secondary, and tertiary health services.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lifestyle course.

    Behavioral

    Pharmacotherapy

  • Bariatric surgery.

    Procedure/Surgery

    Sleeve gastrectomy or gastric bypass.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Non-surgical group.1 intervention
Group B: Surgical group1 intervention

Trial outcomes

Primary outcomes

1

Changes in probing depth (PD)

PD: The vertical distance from the gingival margin to the probable base of the pocket in mm.

Time frame
18 months.
2

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.

Time frame
18 months.

Secondary outcomes

1

Bleeding on probing (BoP).

At site level, BoP will be recorded as present upon gentle probing to the base of the pocket.

Time frame
18 months.
2

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.

Time frame
18 months.
3

Unstimulated saliva.

Salivary collection will be performed directly into a sterile tube (Epperdorf North America, Hauppauge, NY).

Time frame
18 months.
4

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.

Time frame
18 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bergen

Lead sponsor

Haukeland University Hospital

Collaborator

University of North Carolina, Chapel Hill

Collaborator

This trial is not recruiting at the moment. You can still explore other options: