Dietary Collagen Peptides and Periodontal Inflammation

Dietary Intake of Collagen Peptides and Its Effects on Periodontal Inflammation - a Randomized Clinical Trial

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 gingival and periodontal inflammation in a cohort of patients suffering from periodontal disease.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Dietary supplement: collagen peptide test; Dietary supplement: collagen peptide placebo

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 observational clinical trial involving periodontitis patients suggest that the adjunctive consumption of bio-active collagen peptides may also improve the outcome of established periodontitis therapy comprising the professional mechanical removal of disease-associated bacterial biofilms from exposed root surfaces.

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular, 3-month consumption of collagen peptides on clinical and microbiological parameter of periodontal health in a cohort of periodontal recall patients with the following endpoints:

Primary Endpoint:

Change in the percentage of periodontal pockets being positive for bleeding on probing (BoP) after the consumption of the collagen peptides in comparison to the consumption of a placebo product

Secondary Endpoints:

1. changes in probing pocket depth (PPD)
2. changes in clinical attachment level (CAL)
3. changes in the periodontal inflammatory load as assessed by the calculation of the periodontal inflamed surface area (PISA) index
4. changes in Gingival Index (GI) scores
5. changes in Plaque Control Record (PCR) scores
6. changes in Plaque Index scores
7. changes in the composition of the sulcular/pocket microbiota
8. changes in the composition of the intestinal microbiota

Examiner calibration is performed before the onset of the trial and is repeated in 8 weeks intervals throughout the trial.

Sample Size Calculation As this is the first controlled clinical trial evaluating the impact of collagen peptide consumption on the extent of periodontal inflammation, sample size calculation is based on substitute data from preceding studies demonstrating an increase in tissue healing by up to 30%.

With a given difference of 30% reduction in the number of bleeding periodontal pockets (BoP) and an assumed standard deviation of 30% , sample size calculation resulted in a minimum of 19 subjects per group in order to be able to statistically verify differences with a power of 80%, and p<0.05.

Chi-square-test with maximum likelihood method will be used for the analysis of categorical variables, Mann-Whitney U-test will be used for the analysis of independent samples, and Wilcoxon signed rank test for the analysis of paired samples. The level of significance will be set to p≤0.05.

Study patients will be recruited from periodontitis patients seeking routine periodontal maintenance care comprising professional mechanical plaque removal (PMPR) at the Dept. of Periodontology of the University Hospital Wuerzburg.

At baseline prior to the performance of PMPR all above-mentioned study parameters will be recorded. Subsequently the study participants will be randomly assigned to the experimental groups (test/placebo) and a supply of the assigned product (test/placebo) will be given to them with the instruction to consume it 1 x daily for the 3-month duration of the trial.

At 2 months (visit 2) and at 3 months (end of study) after the baseline examination all clinical and microbiological parameters will be reassessed.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97070
    • Dept. of Periodontology, University Hospital Wuerzburg
  • Wuerzburg, Germany, D-97070
    • Section of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: collagen peptide test; 1 x daily consumption of 1 blister package of the collagen-peptide test powder dissolved in water over a period of 90 days	Dietary supplement: collagen peptide test; Collagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm.; Other Names: collagen peptide placebo
PLACEBO_COMPARATOR: collagen peptide placebo; 1y daily consumption of 1 blister package of the placebo powder dissolved in water over a period of 90 days	Dietary supplement: collagen peptide placebo; collagen peptide placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of periodontal sites being positive for bleeding on probing (BoP)	Bleeding on probing will be recorded at 6 sites per tooth after gentle probing of the periodontal sulcus/pocket.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment level (CAL)	clinical attachment level will be assessed using a manual periodontal probe	90 days
pocket probing depth (PPD)	pocket depth will be assessed using a manual periodontal probe	90 days
periodontal inflamed surface area (PISA)	PISA values will be calculated using the recorded BoP, CAL and PPD data	90 days
modified Gingival Index	The modified Gingival Index will be recorded from the buccal aspect of all teeth	90 days
Plaque Control Record	The extension of plaque along the gingival margin will be assessed from the mesial, distal, buccal and oral aspects of all teeth using a standard periodontal probe.	90 days
Plaque Index	The Plaque Index will be recorded from the vestibular aspects of the teeth 16, 21, 24, 36, 41, 44	90 days
Composition of the oral microbiota	Subgingival plaque samples will be collected by paper points from the 4 deepest periodontal pockets of each patient and subsequently analysed by whole genome sequencing	90 days
Composition of the intestinal microbiota	Stool samples will be collected from each study participant and subsequently analysed by whole genome sequencing	90 days

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Yvonne Jockel-Schneider, Dr., Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): August 26, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: gingivitis; plaque; collagen peptide
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis
• Other Study ID Numbers: VERIPA17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No