- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516201
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
Conditions
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
-
-
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Göttingen, Germany, 37085
- Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen
-
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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.
Sponsor
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
Keywords
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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