Periodontal DiseaseNCT06933797
Evaluation of the Potential Effects of LRP5 and Tph1 in the Pathogenesis of Periodontal Disease Individuals With Stage III Grade B Periodontitis
An observational study of Periodontal Disease and Periodontitis (Stage 3), run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: The aim of this study was to determine the changes in LRP5 and TPH1 levels in serum and saliva samples due to periodontal inflammation and to evaluate the relationship between these values and clinical periodontal parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Periodontitis (Stage 3), Periodontitis Stage III
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 25 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of patients with stage III periodontitis and periodontally healthy patients admitted to Ankara University Faculty of Dentistry Clinic.
Who may be able to join
- >18 years old,
- At least 16 permanent teeth except 3rd molars,
- Individuals who do not use orthodontic appliances,
- Individuals who are not pregnant or lactating,
- Individuals without any systemic disease that may affect periodontal health,
- Systemically healthy individuals,
- Individuals who have not used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
- Individuals who have not received periodontal treatment in the last 1 year
Who cannot join
- Pregnant/lactating individuals,
- Individuals who have used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
- Individuals who have undergone periodontal treatment in the last 1 year,
- Individuals with psychiatric illness,
- Individuals with any oral infection,
- Individuals with <16 teeth, excluding molars,
Show all 9Show fewer
- Individuals with alcohol dependence,
- Individuals with active infectious disease (acute hepatitis, AIDS, tuberculosis), cancer or any systemic condition that may affect periodontal tissues,
- Individuals receiving treatment with drugs known to affect periodontal tissues (phenytoin, cyclosporine A, calcium channel blockers)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry,
Ankara, Yenimahalle, 06500
About this study
Official title: Evaluation of the Changes in LRP5 and TPH1 Levels Due to Periodontal Inflammation
Objectives: The aim of this study was to determine the changes in LRP5 and TPH1 levels in serum and saliva samples due to periodontal inflammation and to evaluate the relationship between these values and clinical periodontal parameters.
Methods: Saliva and serum samples were collected from 20 systemically healthy patients with Stage III periodontitis and 20 periodontally healthy control individuals. Salivary and serum LRP5 and TPH1 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Clinical periodontal parameters, including plaque index (PI), probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL), were recorded.
- Keywords
- Low-density lipoprotein receptor-associated protein 5, Tryptophan Hydroxylase 1, Periodontitis
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage III periodontitis | Individuals exhibiting pocket depths of >3 mm in at least two non-adjacent teeth, radiographic evidence of alveolar bone loss extending to the middle or apical third of the root, and tooth loss of ≤4 due to periodontitis were classified as having Stage III periodontitis. The additional criterion for Grade B classification was defined as a % bone loss/age ratio of 0.25-1. | |
| Periodontally healthy | Individuals with no signs of alveolar bone loss and an overall oral bleeding score <10% were categorized as periodontally healthy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LRP5
Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) is a WNT coreceptor in the LRP superfamily involved in a wide range of biological processes including endocytosis, cellular communication, lipid homeostasis and embryonic development. The levels of LRP5 in both serum and saliva samples were determined using commercially available ELISA kits. All assays were conducted according to the manufacturers' instructions.
Measured: 1 month
TPH1
The inhibitory, irreversible enzyme of serotonin synthesis from intestinal cells is tryptophan hydroxylase 1 (TPH1). The levels of TPH1 in both serum and saliva samples were determined using commercially available ELISA kits. All assays were conducted according to the manufacturers' instructions.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Zulal Deniz Guner, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933797
- Sponsor's protocol ID
- 36290600/03/2024
- Other IDs
- 1919B012319473
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yadav VK, Ryu JH, Suda N, Tanaka KF, Gingrich JA, Schutz G, Glorieux FH, Chiang CY, Zajac JD, Insogna KL, Mann JJ, Hen R, Ducy P, Karsenty G. Lrp5 controls bone formation by inhibiting serotonin synthesis in the duodenum. Cell. 2008 Nov 28;135(5):825-37. doi: 10.1016/j.cell.2008.09.059.
PubMed 19041748Jiang H, Xi Y, Jiang Q, Dai W, Qin X, Zhang J, Jiang Z, Yang G, Chen Q. LRP5 Down-Regulation Exacerbates Inflammation and Alveolar Bone Loss in Periodontitis by Inhibiting PI3K/c-FOS Signalling. J Clin Periodontol. 2025 Apr;52(4):637-650. doi: 10.1111/jcpe.14112. Epub 2025 Jan 21.
PubMed 39837316
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Changes in LRP5 and TPH1 Levels Due to Periodontal Inflammation
- ClinicalTrials.gov ID
- NCT06933797
- Acronym / sponsor ID
- 36290600/03/2024
- Keywords
- Low-density lipoprotein receptor-associated protein 5, Tryptophan Hydroxylase 1, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 18 Apr 2025 (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.
Objectives: The aim of this study was to determine the changes in LRP5 and TPH1 levels in serum and saliva samples due to periodontal inflammation and to evaluate the relationship between these values and clinical periodontal parameters.
Methods: Saliva and serum samples were collected from 20 systemically healthy patients with Stage III periodontitis and 20 periodontally healthy control individuals. Salivary and serum LRP5 and TPH1 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Clinical periodontal parameters, including plaque index (PI), probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL), were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage III periodontitis | – | –Individuals exhibiting pocket depths of >3 mm in at least two non-adjacent teeth, radiographic evidence of alveolar bone loss extending to the middle or apical third of the root, and tooth loss of ≤4 due to periodontitis were classified as having Stage III periodontitis. The additional criterion for Grade B classification was defined as a % bone loss/age ratio of 0.25-1. |
| Periodontally healthy | – | –Individuals with no signs of alveolar bone loss and an overall oral bleeding score <10% were categorized as periodontally healthy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients with stage III periodontitis and periodontally healthy patients admitted to Ankara University Faculty of Dentistry Clinic.
Key inclusion criteria (8 listed)
- >18 years old,
- At least 16 permanent teeth except 3rd molars,
- Individuals who do not use orthodontic appliances,
- Individuals who are not pregnant or lactating,
- Individuals without any systemic disease that may affect periodontal health,
Key exclusion criteria (9 listed)
- Pregnant/lactating individuals,
- Individuals who have used anti-inflammatory and/or anti-microbial drugs in the last 6 months,
- Individuals who have undergone periodontal treatment in the last 1 year,
- Individuals with psychiatric illness,
- Individuals with any oral infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LRP5
Time frame: 1 month
Low-density lipoprotein (LDL) receptor-related protein 5 (LRP5) is a WNT coreceptor in the LRP superfamily involved in a wide range of biological processes including endocytosis, cellular communication, lipid homeostasis and embryonic development. The levels of LRP5 in both serum and saliva samples were determined using commercially available ELISA kits. All assays were conducted according to the manufacturers' instructions.
TPH1
Time frame: 1 month
The inhibitory, irreversible enzyme of serotonin synthesis from intestinal cells is tryptophan hydroxylase 1 (TPH1). The levels of TPH1 in both serum and saliva samples were determined using commercially available ELISA kits. All assays were conducted according to the manufacturers' instructions.
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 18 Apr 2025.
- Results publication: PubMed 19041748Yadav VK, Ryu JH, Suda N, Tanaka KF, Gingrich JA, Schutz G, Glorieux FH, Chiang CY, Zajac JD, Insogna KL, Mann JJ, Hen R, Ducy P, Karsenty G. Lrp5 controls bone formation by inhibiting serotonin synthesis in the duodenum. Cell. 2008 Nov 28;135(5):825-37. doi: 10.1016/j.cell.2008.09.059.
- Results publication: PubMed 39837316Jiang H, Xi Y, Jiang Q, Dai W, Qin X, Zhang J, Jiang Z, Yang G, Chen Q. LRP5 Down-Regulation Exacerbates Inflammation and Alveolar Bone Loss in Periodontitis by Inhibiting PI3K/c-FOS Signalling. J Clin Periodontol. 2025 Apr;52(4):637-650. doi: 10.1111/jcpe.14112. Epub 2025 Jan 21.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Periodontal Disease and Periodontitis (Stage 3), run by Ankara University 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 8 inclusion and 9 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 18 Apr 2025. 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. 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?
LRP5 (time frame: 1 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?
On the ClinicalTrials.gov record for NCT06933797, which also lists 2 linked publications.
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 18 Apr 2025.