Obesity and Oral Diseases in Adult Patients

NCT04602572 | Not Yet Recruiting

• 1 other identifier: 152810
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Oral Diseases; Periodontitis; Dental Caries; Dental Erosion

Keywords

Obesity; Overweight; Periodontitis; Caries; Bariatric surgery; Oral health

Outcome Measures

Primary Outcomes (2)

• Changes in probing depth (PD)

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

  18 months.

• 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 Outcomes (7)

• Bleeding on probing (BoP).

  18 months.

• Gingival crevicular fluid (GCF).

  18 months.

• Unstimulated saliva.

  18 months.

• Whole blood

  18 months.

• Tooth loss

  18 months

Study Arms (2)

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.

Behavioral: Lifestyle course.

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.

Procedure: Bariatric surgery.

Interventions

Lifestyle course. BEHAVIORAL

Pharmacotherapy

Non-surgical group.

Bariatric surgery. PROCEDURE

Sleeve gastrectomy or gastric bypass.

Surgical group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Obese adult patients.
• Patients referred to the Obesity Clinic at the Hospital.

You may not qualify if:

• Unwillingness to participate.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• University of North Carolina, Chapel Hill: collaborator

Related Publications (22)

• Marsicano JA, Sales-Peres A, Ceneviva R, de C Sales-Peres SH. Evaluation of oral health status and salivary flow rate in obese patients after bariatric surgery. Eur J Dent. 2012 Apr;6(2):191-7.

  PMID: 22509123 BACKGROUND

• Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24.

  PMID: 27219496 BACKGROUND

• Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

  PMID: 26641646 BACKGROUND

• Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15.

  PMID: 25590212 BACKGROUND

• Barbosa CS, Barberio GS, Marques VR, Baldo Vde O, Buzalaf MA, Magalhaes AC. Dental manifestations in bariatric patients: review of literature. J Appl Oral Sci. 2009;17 Suppl(spe):1-4. doi: 10.1590/s1678-77572009000700002.

  PMID: 21499648 BACKGROUND

• Costa RC, Yamaguchi N, Santo MA, Riccioppo D, Pinto-Junior PE. Outcomes on quality of life, weight loss, and comorbidities after Roux-en-Y gastric bypass. Arq Gastroenterol. 2014 Jul-Sep;51(3):165-70. doi: 10.1590/s0004-28032014000300002.

  PMID: 25296074 BACKGROUND

• Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, Heinberg LJ, Kushner R, Adams TD, Shikora S, Dixon JB, Brethauer S; American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013 Mar;21 Suppl 1(0 1):S1-27. doi: 10.1002/oby.20461.

  PMID: 23529939 BACKGROUND

• Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

  PMID: 17715408 BACKGROUND

• Poirier P, Cornier MA, Mazzone T, Stiles S, Cummings S, Klein S, McCullough PA, Ren Fielding C, Franklin BA; American Heart Association Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Bariatric surgery and cardiovascular risk factors: a scientific statement from the American Heart Association. Circulation. 2011 Apr 19;123(15):1683-701. doi: 10.1161/CIR.0b013e3182149099. Epub 2011 Mar 14. No abstract available.

  PMID: 21403092 BACKGROUND

• Basoglu OK, Vardar R, Tasbakan MS, Ucar ZZ, Ayik S, Kose T, Bor S. Obstructive sleep apnea syndrome and gastroesophageal reflux disease: the importance of obesity and gender. Sleep Breath. 2015 May;19(2):585-92. doi: 10.1007/s11325-014-1051-4. Epub 2014 Aug 31.

  PMID: 25173794 BACKGROUND

• Jastrzebska-Mierzynska M, Ostrowska L, Wasiluk D, Konarzewska-Duchnowska E. Dietetic recommendations after bariatric procedures in the light of the new guidelines regarding metabolic and bariatric surgery. Rocz Panstw Zakl Hig. 2015;66(1):13-9.

  PMID: 25813068 BACKGROUND

• Netto BD, Moreira EA, Patino JS, Beninca JP, Jordao AA, Frode TS. Influence of Roux-en-Y gastric bypass surgery on vitamin C, myeloperoxidase, and oral clinical manifestations: a 2-year follow-up study. Nutr Clin Pract. 2012 Feb;27(1):114-21. doi: 10.1177/0884533611431462.

  PMID: 22307495 BACKGROUND

• de Moura-Grec PG, Yamashita JM, Marsicano JA, Ceneviva R, de Souza Leite CV, de Brito GB, Brienze SL, de Carvalho Sales-Peres SH. Impact of bariatric surgery on oral health conditions: 6-months cohort study. Int Dent J. 2014 Jun;64(3):144-9. doi: 10.1111/idj.12090. Epub 2014 Jan 11.

  PMID: 24410073 BACKGROUND

• Meyle J, Chapple I. Molecular aspects of the pathogenesis of periodontitis. Periodontol 2000. 2015 Oct;69(1):7-17. doi: 10.1111/prd.12104.

  PMID: 26252398 BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet. 2016 Apr 2;387(10026):1377-1396. doi: 10.1016/S0140-6736(16)30054-X.

  PMID: 27115820 BACKGROUND

• Dye BA. Global periodontal disease epidemiology. Periodontol 2000. 2012 Feb;58(1):10-25. doi: 10.1111/j.1600-0757.2011.00413.x. No abstract available.

  PMID: 22133364 BACKGROUND

• Karlsson L, Carlsson J, Jenneborg K, Kjaeldgaard M. Perceived oral health in patients after bariatric surgery using oral health-related quality of life measures. Clin Exp Dent Res. 2018 Oct 16;4(6):230-240. doi: 10.1002/cre2.134. eCollection 2018 Dec.

  PMID: 30603104 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Scott DA, Palmer RM, Stapleton JA. Validation of smoking status in clinical research into inflammatory periodontal disease. J Clin Periodontol. 2001 Aug;28(8):715-22. doi: 10.1034/j.1600-051x.2001.280801.x. English, French, German.

  PMID: 11442730 BACKGROUND

• Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107.

  PMID: 26662482 BACKGROUND

• Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.

  PMID: 28306142 BACKGROUND

• Nilsen A, Thorsnes A, Lie SA, Methlie P, Bunaes DF, Reinholtsen KK, Leknes KN. Periodontitis in obese adults with and without metabolic syndrome: a cross-sectional study. BMC Oral Health. 2023 Jul 1;23(1):439. doi: 10.1186/s12903-023-03133-5.

  PMID: 37393272 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Obesity; Periodontitis; Dental Caries; Tooth Erosion; Overweight

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Knut N Leknes, Professor

  Bergen5032#

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Knut N Leknes, Professor

CONTACT

98474477; knut.leknes@uib.no

Paal Methlie, Consultant

CONTACT

97677930; paal.methlie@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share