GingivitisNCT03765125
Dietary Collagen Peptides and Periodontal Inflammation
A study testing collagen peptide test in people with Gingivitis, run by Wuerzburg University Hospital at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- collagen peptide test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Dept. of Periodontology, University Hospital Wuerzburg
Würzburg, 97070
Section of Periodontology
Würzburg, D-97070
About this study
Official title: 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.
Read the 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:
- changes in probing pocket depth (PPD)
- changes in clinical attachment level (CAL)
- changes in the periodontal inflammatory load as assessed by the calculation of the periodontal inflamed surface area (PISA) index
- changes in Gingival Index (GI) scores
- changes in Plaque Control Record (PCR) scores
- changes in Plaque Index scores
- changes in the composition of the sulcular/pocket microbiota
- 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.
- Conditions
- Gingivitis
- Being tested
- collagen peptide test, collagen peptide placebo
- Keywords
- gingivitis, collagen peptide, plaque
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen peptide testDietary supplement
Also called collagen peptide placebo
Collagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm.
collagen peptide placeboDietary supplement
collagen peptide placebo
| Study group | Role | What they receive |
|---|---|---|
| collagen peptide test | Experimental | 1 x daily consumption of 1 blister package of the collagen-peptide test powder dissolved in water over a period of 90 days Receives: Dietary Supplement: collagen peptide test |
| collagen peptide placebo | Placebo comparator | 1y daily consumption of 1 blister package of the placebo powder dissolved in water over a period of 90 days Receives: Dietary Supplement: collagen peptide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (8)
clinical attachment level (CAL)
clinical attachment level will be assessed using a manual periodontal probe
Measured: 90 days
pocket probing depth (PPD)
pocket depth will be assessed using a manual periodontal probe
Measured: 90 days
periodontal inflamed surface area (PISA)
PISA values will be calculated using the recorded BoP, CAL and PPD data
Measured: 90 days
modified Gingival Index
The modified Gingival Index will be recorded from the buccal aspect of all teeth
Measured: 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.
Measured: 90 days
Plaque Index
The Plaque Index will be recorded from the vestibular aspects of the teeth 16, 21, 24, 36, 41, 44
Measured: 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
Measured: 90 days
Composition of the intestinal microbiota
Stool samples will be collected from each study participant and subsequently analysed by whole genome sequencing
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Sep 2018
- Primary completion26 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled 2-arm, parallel group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Jockel-Schneider, Dr., Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765125
- Sponsor's protocol ID
- VERIPA17
- Status last verified
- Apr 2019
- First submitted
- 3 Dec 2018
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake of Collagen Peptides and Its Effects on Periodontal Inflammation - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03765125
- Acronym / sponsor ID
- VERIPA17
- Conditions
- Gingivitis
- Keywords
- gingivitis, collagen peptide, plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- changes in probing pocket depth (PPD)
- changes in clinical attachment level (CAL)
- changes in the periodontal inflammatory load as assessed by the calculation of the periodontal inflamed surface area (PISA) index
- changes in Gingival Index (GI) scores
- changes in Plaque Control Record (PCR) scores
- changes in Plaque Index scores
- changes in the composition of the sulcular/pocket microbiota
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled 2-arm, parallel group
| Arm | Type | Receives |
|---|---|---|
| collagen peptide test | Experimental | Dietary Supplement: collagen peptide test1 x daily consumption of 1 blister package of the collagen-peptide test powder dissolved in water over a period of 90 days |
| collagen peptide placebo | Placebo comparator | Dietary Supplement: collagen peptide placebo1y daily consumption of 1 blister package of the placebo powder dissolved in water over a period of 90 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagen peptide testAlso: collagen peptide placeboCollagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm. | Dietary supplement | collagen peptide test |
| collagen peptide placebocollagen peptide placebo | Dietary supplement | collagen peptide placebo |
Primary outcome
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.
8 secondary outcomes
clinical attachment level (CAL)
Time frame: 90 days
pocket probing depth (PPD)
Time frame: 90 days
periodontal inflamed surface area (PISA)
Time frame: 90 days
modified Gingival Index
Time frame: 90 days
Plaque Control Record
Time frame: 90 days
Plaque Index
Time frame: 90 days
Composition of the oral microbiota
Time frame: 90 days
Composition of the intestinal microbiota
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Jockel-Schneider, Dr. principal investigator
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen peptide test in people with Gingivitis, run by Wuerzburg University Hospital at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of periodontal sites being positive for bleeding on probing (BoP) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.