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Dietary Collagen Peptides and Periodontal Inflammation

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: NCT03765125
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

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

Condition or disease Intervention/treatment Phase
Gingivitis Dietary Supplement: collagen peptide test Dietary Supplement: collagen peptide placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled 2-arm, parallel group
Masking: Double (Participant, Investigator)
Masking Description: test and placebo powder contained in coded blister packages of identical shape and colour Handing out of the assigned powder by a study nurse not involved in the clinical examination and data collection
Primary Purpose: Treatment
Official Title: Dietary Intake of Collagen Peptides and Its Effects on Periodontal Inflammation - a Randomized Clinical Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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 Name: 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




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


Secondary Outcome Measures :
  1. clinical attachment level (CAL) [ Time Frame: 90 days ]
    clinical attachment level will be assessed using a manual periodontal probe

  2. pocket probing depth (PPD) [ Time Frame: 90 days ]
    pocket depth will be assessed using a manual periodontal probe

  3. periodontal inflamed surface area (PISA) [ Time Frame: 90 days ]
    PISA values will be calculated using the recorded BoP, CAL and PPD data

  4. modified Gingival Index [ Time Frame: 90 days ]
    The modified Gingival Index will be recorded from the buccal aspect of all teeth

  5. Plaque Control Record [ Time Frame: 90 days ]
    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.

  6. Plaque Index [ Time Frame: 90 days ]
    The Plaque Index will be recorded from the vestibular aspects of the teeth 16, 21, 24, 36, 41, 44

  7. Composition of the oral microbiota [ Time Frame: 90 days ]
    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

  8. Composition of the intestinal microbiota [ Time Frame: 90 days ]
    Stool samples will be collected from each study participant and subsequently analysed by whole genome sequencing



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03765125


Locations
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Germany
Dept. of Periodontology, University Hospital Wuerzburg
Wuerzburg, Germany, 97070
Section of Periodontology
Wuerzburg, Germany, D-97070
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Yvonne Jockel-Schneider, Dr. Wuerzburg University Hospital
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03765125    
Other Study ID Numbers: VERIPA17
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Wuerzburg University Hospital:
gingivitis
collagen peptide
plaque
Additional relevant MeSH terms:
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Gingivitis
Inflammation
Pathologic Processes
Infections
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases