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Oral Health in Bariatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516201
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University of Göttingen

Study Description
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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.

Condition or disease
Adiposity Dental Diseases Bariatric Surgery Candidate

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
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Oral Health in Bariatric Patients
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : February 12, 2020
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oral health of obese adults without bariatric surgery - attachment loss [ Time Frame: 10-15 Minutes ]
    probing depths (mm) + recessions (mm)

  2. Oral health of obese adults without bariatric surgery - BOP [ Time Frame: 2 Minutes ]
    BOP (Bleeding on probing, %) as indicator of inflammation

  3. 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

  4. Oral health of obese adults without bariatric surgery - erosive tooth wear [ Time Frame: 1-2 Minutes ]
    BEWE (Basic erosive wear examination, 0-3)


Secondary Outcome Measures :
  1. Oral health of obese adults after bariatric surgery - attachment loss [ Time Frame: 10-15 Min ]
    probing depths (mm) + recessions (mm)

  2. Oral health of obese adults after bariatric surgery - BOP [ Time Frame: 2 Minutes ]
    BOP (Bleeding on probing, %) as indicator of inflammation

  3. 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

  4. Oral health of obese adults after bariatric surgery - erosive tooth wear [ Time Frame: 1-2 Minutes ]
    BEWE (Basic erosive wear examination, 0-3)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516201


Locations
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Germany
Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen
Göttingen, Germany, 37085
Sponsors and Collaborators
University of Göttingen
Investigators
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Study Director: Annette Wiegand, Prof. Dr. med. dent. Dept. of Prev. Dentistry, Periodontology and Cariology
More Information
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Responsible Party: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Postdoctoral Research Fellow, University of Göttingen
ClinicalTrials.gov Identifier: NCT03516201    
Other Study ID Numbers: 28/3/17
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University of Göttingen:
bariatric surgery
Periodontitis
Caries
erosive tooth wear
 Gingivitis
BMI
oral health
obesity
Additional relevant MeSH terms:
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Stomatognathic Diseases