Clinical trial NCT03516201: Oral Health in Bariatric Patients
Official title: Oral Health in Bariatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adiposity
Dental Diseases
Bariatric Surgery Candidate
Keywords: bariatric surgery
Periodontitis
Caries
erosive tooth wear
Gingivitis
BMI
oral health
obesity
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolls obese adults (Age over 18 years) with an BMI (body mass index) of at least 25 kg/m2 without or after bariatric surgery

Brief summary: As few is known about the oral health of bariatric patients, this study aimed to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Detailed description: The prevalence of overweight and obesity is increasing since the 1980s. Being associated with several risk factors such as hypertension, hyperinsulinemia and hyperlipidemia, obesity presents an immediate and long-term health risk for diabetes mellitus, heart diseases, osteoarthritis and certain forms of cancer. For the control of obesity several therapy options have been developed: Beside conservative treatments including change of diet and lifestyle, bariatric surgery is considered as a promising option for patients with severe obesity (BMI ≥ 40 kg/m2). Allowing impressive weight loss from 40 to 80% and effective reduction of comorbidities, bariatric surgery shows some negative/adverse effects as well, like kidney problems, hyperparathyroidism, anemia and metabolic bone diseases. For oral health, two facts are particularly important to consider: Firstly, chronic regurgitation reaching the oral cavity is an important risk factor for erosive tooth wear which initially appear as smooth silky-shining glazed surfaces. Further progress is often associated with hypersensitivities and aesthetic deficits. Over time, often substantial loss can been observed, provoking hypersensitivities and aesthetic deficits. Secondly, depending on the type of bariatric surgery, pronounced postoperative metabolic and nutritional changes can be observed which also might influence oral health. Aim of this study is to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* BMI ≥ 25 kg/m2 without or after bariatric surgery

Exclusion Criteria:

* refusal for participation
* age \<18 years
* BMI \<25 kg/m2

Primary outcomes:
measure: Oral health of obese adults without bariatric surgery - attachment loss
timeFrame: 10-15 Minutes
measure: Oral health of obese adults without bariatric surgery - BOP
timeFrame: 2 Minutes
measure: Oral health of obese adults without bariatric surgery - dental caries
timeFrame: 2-5 Minutes
measure: Oral health of obese adults without bariatric surgery - erosive tooth wear
timeFrame: 1-2 Minutes
Secondary outcomes:
measure: Oral health of obese adults after bariatric surgery - attachment loss
timeFrame: 10-15 Min
measure: Oral health of obese adults after bariatric surgery - BOP
timeFrame: 2 Minutes
measure: Oral health of obese adults after bariatric surgery - dental caries
timeFrame: 2-5 Minutes
measure: Oral health of obese adults after bariatric surgery - erosive tooth wear
timeFrame: 1-2 Minutes
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen
Study officials:
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology
name: Annette Wiegand, Prof. Dr. med. dent.
role: STUDY_DIRECTOR
References: