NCT06933797

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 8, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

Low-density lipoprotein receptor-associated protein 5Tryptophan Hydroxylase 1Periodontitis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of patients with stage III periodontitis and periodontally healthy patients admitted to Ankara University Faculty of Dentistry Clinic.

You may qualify if:

  • \>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

You may not qualify if:

  • 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,
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry,

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 19041748BACKGROUND
  • Jiang 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.

    PMID: 39837316BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 18, 2025

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

February 25, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

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