NCT03516201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

March 21, 2018

Last Update Submit

January 24, 2026

Conditions

Keywords

bariatric surgeryPeriodontitisCarieserosive tooth wearGingivitisBMIoral healthobesity

Outcome Measures

Primary Outcomes (4)

  • Oral health of obese adults without bariatric surgery - attachment loss

    probing depths (mm) + recessions (mm)

    10-15 Minutes

  • Oral health of obese adults without bariatric surgery - BOP

    BOP (Bleeding on probing, %) as indicator of inflammation

    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

    2-5 Minutes

  • Oral health of obese adults without bariatric surgery - erosive tooth wear

    BEWE (Basic erosive wear examination, 0-3)

    1-2 Minutes

Secondary Outcomes (4)

  • Oral health of obese adults after bariatric surgery - attachment loss

    10-15 Min

  • Oral health of obese adults after bariatric surgery - BOP

    2 Minutes

  • Oral health of obese adults after bariatric surgery - dental caries

    2-5 Minutes

  • Oral health of obese adults after bariatric surgery - erosive tooth wear

    1-2 Minutes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age ≥ 18 years
  • BMI ≥ 25 kg/m2 without or after bariatric surgery

You may not qualify if:

  • refusal for participation
  • age \<18 years
  • BMI \<25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Göttingen, 37075, Germany

Location

MeSH Terms

Conditions

ObesityStomatognathic DiseasesPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesInfectionsGingival Diseases

Study Officials

  • Annette Wiegand, Prof. Dr. med. dent.

    Dept. of Prev. Dentistry, Periodontology and Cariology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

March 21, 2018

First Posted

May 4, 2018

Study Start

June 15, 2018

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations