Oral Health in Bariatric Patients

November 4, 2020 updated by: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University of Göttingen
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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Göttingen, Germany, 37085
        • Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
obese patients after bariatric surgery
obese adults (≥ 18 years) who underwent bariatric surgery
obese adultes without bariatric surgery
obese adults (≥ 18 years) who did not underwent bariatric surgery at the time of the examination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health of obese adults after bariatric surgery - attachment loss
Time Frame: 10-15 Min
probing depths (mm) + recessions (mm)
10-15 Min
Oral health of obese adults after bariatric surgery - BOP
Time Frame: 2 Minutes
BOP (Bleeding on probing, %) as indicator of inflammation
2 Minutes
Oral health of obese adults after bariatric surgery - dental caries
Time Frame: 2-5 Minutes
ICDAS (International Caries Detection and Assessment System II, 0-6), presence of restaurations/ crowns (yes/no): calculation of DMFT
2-5 Minutes
Oral health of obese adults after bariatric surgery - erosive tooth wear
Time Frame: 1-2 Minutes
BEWE (Basic erosive wear examination, 0-3)
1-2 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2018

Primary Completion (ACTUAL)

February 12, 2020

Study Completion (ANTICIPATED)

May 1, 2025

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (ACTUAL)

May 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/3/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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