AdiposityNCT03516201
Oral Health in Bariatric Patients
An observational study of Adiposity and Dental Diseases, run by University of Göttingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Dental Diseases, Bariatric Surgery Candidate
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2018to 12 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Age ≥ 18 years
- BMI ≥ 25 kg/m2 without or after bariatric surgery
Who cannot join
- refusal for participation
- age <18 years
- BMI <25 kg/m2
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen
Göttingen, 37075
About this study
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.
Read the 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.
- Conditions
- Adiposity, Dental Diseases, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, Periodontitis, Caries, erosive tooth wear, Gingivitis, BMI, oral health, obesity
- Medical subject headings
- Obesity, Stomatognathic Diseases, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Oral health of obese adults without bariatric surgery - attachment loss
probing depths (mm) + recessions (mm)
Measured: 10-15 Minutes
Oral health of obese adults without bariatric surgery - BOP
BOP (Bleeding on probing, %) as indicator of inflammation
Measured: 2 Minutes
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
Measured: 2-5 Minutes
Oral health of obese adults without bariatric surgery - erosive tooth wear
BEWE (Basic erosive wear examination, 0-3)
Measured: 1-2 Minutes
Secondary outcomes (4)
Oral health of obese adults after bariatric surgery - attachment loss
probing depths (mm) + recessions (mm)
Measured: 10-15 Min
Oral health of obese adults after bariatric surgery - BOP
BOP (Bleeding on probing, %) as indicator of inflammation
Measured: 2 Minutes
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
Measured: 2-5 Minutes
Oral health of obese adults after bariatric surgery - erosive tooth wear
BEWE (Basic erosive wear examination, 0-3)
Measured: 1-2 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start15 Jun 2018
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, Prof. Dr. med. dent., Dr. rer. medic., University of Göttingen
- Investigators
- Annette Wiegand, Prof. Dr. med. dent., Study director, Dept. of Prev. Dentistry, Periodontology and Cariology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516201
- Sponsor's protocol ID
- 28/3/17
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2018
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health in Bariatric Patients
- ClinicalTrials.gov ID
- NCT03516201
- Acronym / sponsor ID
- 28/3/17
- Conditions
- Adiposity, Dental Diseases, Bariatric Surgery Candidate
- Keywords
- bariatric surgery, Periodontitis, Caries, erosive tooth wear, Gingivitis, BMI, oral health, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- BMI ≥ 25 kg/m2 without or after bariatric surgery
Key exclusion criteria (3 listed)
- refusal for participation
- age <18 years
- BMI <25 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral health of obese adults without bariatric surgery - attachment loss
Time frame: 10-15 Minutes
probing depths (mm) + recessions (mm)
Oral health of obese adults without bariatric surgery - BOP
Time frame: 2 Minutes
BOP (Bleeding on probing, %) as indicator of inflammation
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
Oral health of obese adults without bariatric surgery - erosive tooth wear
Time frame: 1-2 Minutes
BEWE (Basic erosive wear examination, 0-3)
4 secondary outcomes
Oral health of obese adults after bariatric surgery - attachment loss
Time frame: 10-15 Min
Oral health of obese adults after bariatric surgery - BOP
Time frame: 2 Minutes
Oral health of obese adults after bariatric surgery - dental caries
Time frame: 2-5 Minutes
Oral health of obese adults after bariatric surgery - erosive tooth wear
Time frame: 1-2 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Wiegand, Prof. Dr. med. dent. study director
Dept. of Prev. Dentistry, Periodontology and Cariology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity and Dental Diseases, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health of obese adults without bariatric surgery - attachment loss (time frame: 10-15 Minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.