Oral Health in Bariatric Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

Oral Health in Bariatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03516201
• Other study ID #: 28/3/17
• Status: Active, not recruiting
• Start date: June 15, 2018
• Est. completion date: May 2025

Study information

• Verified date: November 2020
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Bariatric Surgery Candidate
• Dental Diseases
• Stomatognathic Diseases

Locations

Country	Name	City	State
Germany	Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health of obese adults without bariatric surgery - attachment loss	probing depths (mm) + recessions (mm)	10-15 Minutes
Primary	Oral health of obese adults without bariatric surgery - BOP	BOP (Bleeding on probing, %) as indicator of inflammation	2 Minutes
Primary	Oral health of obese adults without bariatric surgery - dental caries	ICDAS (International Caries Detection and Assessment System II, 0-6), presence of restaurations/ crowns (yes/no): calculation of DMFT	2-5 Minutes
Primary	Oral health of obese adults without bariatric surgery - erosive tooth wear	BEWE (Basic erosive wear examination, 0-3)	1-2 Minutes
Secondary	Oral health of obese adults after bariatric surgery - attachment loss	probing depths (mm) + recessions (mm)	10-15 Min
Secondary	Oral health of obese adults after bariatric surgery - BOP	BOP (Bleeding on probing, %) as indicator of inflammation	2 Minutes
Secondary	Oral health of obese adults after bariatric surgery - dental caries	ICDAS (International Caries Detection and Assessment System II, 0-6), presence of restaurations/ crowns (yes/no): calculation of DMFT	2-5 Minutes
Secondary	Oral health of obese adults after bariatric surgery - erosive tooth wear	BEWE (Basic erosive wear examination, 0-3)	1-2 Minutes