Periodontitis (Stage 3)NCT07683741
Hydrolyzed Collagen As A Host Modulation Agent in Non-Surgical Periodontal Treatment
A study testing Collagen hydrolyzed peptides in people with Periodontitis (Stage 3), run by Hatice Yemenoglu at 1 site in Turkey (Türkiye).
Trial summary
This study was planned on the basis of the hypothesis that 'food supplements containing collagen will support the clinical effectiveness of non-surgical periodontal therapy'. In this context, the aim of the study is to investigate the therapeutic efficacy of collagen-containing food supplement as a host modulation… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- Collagen hydrolyzed peptides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 30 May 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 60 age
- stage 3-4 periodontitis
Who cannot join
- Patients who smoke more than 10 cigarettes a day
- Patients using immunosuppressive, oral contraceptive, bisphosphonate drugs
- Patients who are during pregnancy or lactation
- Having undergone periodontal treatment in the last 6 months, having used antibiotic anti-inflammatory medication in the last 4 weeks
- The presence of any autoimmune disease, osteoporotic disease or cancer disease
- Patients with renal and hepatic insufficiency
Show all 10Show fewer
- Patients with thyroid dysfunction
- The presence of active infectious diseases(acute hepatitis, tuberculosis, AIDS)
- Chronic drug use affecting periodontal tissues(cyclosporine A, Phenytoin)
- Intake of antioxidant supplements
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University
Rize, Rize Province, 53000
About this study
Official title: Investigation of the Host Modulator Efficacy of Food Supplement Containing Hydrolyzed Collagen in Non-Surgical Periodontal Treatment of Patients With Periodontitis
This study was planned on the basis of the hypothesis that 'food supplements containing collagen will support the clinical effectiveness of non-surgical periodontal therapy'. In this context, the aim of the study is to investigate the therapeutic efficacy of collagen-containing food supplement as a host modulation agent in the non-surgical periodontal treatment of individuals with stage 3-4 periodontitis in a clinical and biochemical manner in a comprehensive manner.
Initial day: Anamnesis, diagnosis and index measurements 2 days later, collection of serum samples from the patient, oral hygiene training and straightening of the whole mouth root surface and cleaning of the whole mouth tooth surface The next day, full mouth scalling and root planing are closed with the second session and tablets are started.
Read more
End of 2nd month:
Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
End of 6th month Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
- Conditions
- Periodontitis (Stage 3)
- Being tested
- Collagen hydrolyzed peptides, Placebo + cognitive behavioral therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen hydrolyzed peptidesDietary supplement
Collagen supplements will not be given in the placebo group.
Placebo + cognitive behavioral therapyOther
placebo will be given.
| Study group | Role | What they receive |
|---|---|---|
| Patients using collagen peptides | Active comparator | Not described Receives: Dietary Supplement: Collagen hydrolyzed peptides |
| placebo group | Placebo comparator | Not described Receives: Other: Placebo + cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
The distance between the gingival margin and the pocket base was measured in millimeters.
Measured: baseline, 1st month and 3rd month
clinical attachment loss
The distance from the enamel-cementum junction to the pocket base was measured in millimeters.
Measured: baseline, 1st month and 3th month
Secondary outcomes (2)
assessment of interleukin-1 beta levels
Serum interleukin-1 beta levels were measured biochemically.
Measured: baseline, 1st month and 3th month
assessment of matrix metalloproteinase-8 (MMP-8) levels
Matrix metalloproteinase-8 (MMP-8) levels in gingival crevicular fluid were measured biochemically.
Measured: baseline, 1st month and 3 th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Feb 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Yemenoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Yemenoglu, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683741
- Sponsor's protocol ID
- RTEU Collagen Preparate
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared for appropriate reasons if requested.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Host Modulator Efficacy of Food Supplement Containing Hydrolyzed Collagen in Non-Surgical Periodontal Treatment of Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07683741
- Acronym / sponsor ID
- RTEU Collagen Preparate
- Conditions
- Periodontitis (Stage 3)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hatice YemenogluUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 6 Jul 2026 (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 study was planned on the basis of the hypothesis that 'food supplements containing collagen will support the clinical effectiveness of non-surgical periodontal therapy'. In this context, the aim of the study is to investigate the therapeutic efficacy of collagen-containing food supplement as a host modulation agent in the non-surgical periodontal treatment of individuals with stage 3-4 periodontitis in a clinical and biochemical manner in a comprehensive manner.
Initial day: Anamnesis, diagnosis and index measurements 2 days later, collection of serum samples from the patient, oral hygiene training and straightening of the whole mouth root surface and cleaning of the whole mouth tooth surface The next day, full mouth scalling and root planing are closed with the second session and tablets are started.
End of 2nd month:
Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
End of 6th month Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients using collagen peptides | Active comparator | Dietary Supplement: Collagen hydrolyzed peptides |
| placebo group | Placebo comparator | Other: Placebo + cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 - 60 age
- stage 3-4 periodontitis
Key exclusion criteria (10 listed)
- Patients who smoke more than 10 cigarettes a day
- Patients using immunosuppressive, oral contraceptive, bisphosphonate drugs
- Patients who are during pregnancy or lactation
- Having undergone periodontal treatment in the last 6 months, having used antibiotic anti-inflammatory medication in the last 4 weeks
- The presence of any autoimmune disease, osteoporotic disease or cancer disease
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 hydrolyzed peptidesCollagen supplements will not be given in the placebo group. | Dietary supplement | Patients using collagen peptides |
| Placebo + cognitive behavioral therapyplacebo will be given. | Other | placebo group |
Primary outcome
probing pocket depth
Time frame: baseline, 1st month and 3rd month
The distance between the gingival margin and the pocket base was measured in millimeters.
clinical attachment loss
Time frame: baseline, 1st month and 3th month
The distance from the enamel-cementum junction to the pocket base was measured in millimeters.
2 secondary outcomes
assessment of interleukin-1 beta levels
Time frame: baseline, 1st month and 3th month
assessment of matrix metalloproteinase-8 (MMP-8) levels
Time frame: baseline, 1st month and 3 th month
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 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Data can be shared for appropriate reasons if requested.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen hydrolyzed peptides in people with Periodontitis (Stage 3), run by Hatice Yemenoglu at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
probing pocket depth (time frame: baseline, 1st month and 3rd month). The study lists 2 primary outcomes in all. 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 6 Jul 2026.