Status:
COMPLETED
Dietary Collagen Peptides and Periodontal Inflammation
Lead Sponsor:
Wuerzburg University Hospital
Conditions:
Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of collagen peptides on the clinical signs of gingi...
Detailed Description
The positive influence of the regular consumption of bioactive collagen peptides on connective tissue and skin physiology has already been documented by several clinical trials. Preliminary data of an...
Eligibility Criteria
Inclusion
- number of teeth ≥ 10
- age ≥ 35 ≤ 70 years
- body mass index (BMI) ≥ 24 ≤ 30
- history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
- presence of mild to moderate gingivitis (Gingiva Index \> category GI 0 ≤ category GI 2) at a minimum of 3 teeth
Exclusion
- manifestation of inflammatory oral mucosal diseases other than gingivitis
- xerostomia (salivary flow ≤ 0.1 ml/minute)
- inability for regular oral home care
- inability to follow the study protocol due to intellectual or physical handicaps
- history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years
- current pregnancy
- acute infections as HIV
- existence of metabolic bone disease
- smoking status of more than 10 cigarettes/day
- use of antibiotics and/or anti-inflammatory medication within 4 weeks prior to screening.
- active orthodontic therapy
- diabetes mellitus type I and II
- regular consumption of medications interfering with gingival inflammation (e.g. cortisol)
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03765125
Start Date
September 1 2018
End Date
August 31 2019
Last Update
June 2 2022
Active Locations (2)
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1
Dept. of Periodontology, University Hospital Wuerzburg
Würzburg, Germany, 97070
2
Section of Periodontology
Würzburg, Germany, D-97070