NCT06635369

Brief Summary

Aging leads to a decline in physiological functions and increases the risk of chronic diseases. Periodontitis is a chronic inflammatory disease that causes progressive destruction of the tissues supporting the teeth. Taurine, an amino acid with anti-inflammatory and antioxidant effects, might impact both periodontitis and aging. This study investigated taurine, SIRT1, and TNF-α levels in saliva and blood of 66 healthy people in different age groups, with or without periodontal disease. The findings showed that young people with healthy periodontal status had higher levels of taurine and SIRT1 compared to others. TNF-α, a marker of inflammation, was linked to the severity of periodontitis and may help identifying it in younger individuals. Overall, higher TNF-α levels are associated with periodontal inflammation, while taurine levels decrease with age-related inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 4, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

TaurinePeriodontitisAgingInflammationTNF-αSIRT1Biomarker

Outcome Measures

Primary Outcomes (3)

  • Taurine

    Taurine levels in saliva and serum were measured

    12 Weeks

  • SIRT1

    SIRT1 levels in saliva and serum were measured

    12 Weeks

  • TNF-α

    TNF-α levels in saliva and serum were measured

    12 Weeks

Study Arms (4)

Young (25-44 years) with a healthy periodontium

EXPERIMENTAL
Diagnostic Test: Periodontal Indices

young (25-44 years) with Periodontitis

EXPERIMENTAL
Diagnostic Test: Periodontal Indices

Old (≥65 years) with a healthy periodontium

EXPERIMENTAL
Diagnostic Test: Periodontal Indices

Old (≥65 years) with Periodontitis

EXPERIMENTAL
Diagnostic Test: Periodontal Indices

Interventions

Periodontal IndicesDIAGNOSTIC_TEST

Saliva, serum and periodontal indexes were obtained from patients

Also known as: Salivary Flow Rate, TNF-α Levels, SIRT1 Levels, Taurine Levels
Old (≥65 years) with PeriodontitisOld (≥65 years) with a healthy periodontiumYoung (25-44 years) with a healthy periodontiumyoung (25-44 years) with Periodontitis

Eligibility Criteria

Age26 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • ages 18-25 or 45-64
  • use of antibiotics, anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, or anticoagulants within the last 6 months
  • presence of diabetes, rheumatoid arthritis, or other systemic conditions such as cardiovascular, renal, hepatic, and neurodegenerative disorders
  • pregnancy or lactation
  • alcoholism
  • smoking
  • nonsurgical periodontal treatment in the past 6 months or surgical treatment in the past 12 months
  • having less than 20 natural teeth, excluding third molars
  • use of orthodontic appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Unkapani, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Participants are separated into four different groups. Young (25-44 years) with a healthy periodontium, young with periodontitis, old (≥65 years) with a healthy periodontium, and old with periodontitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd candidate

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 10, 2024

Study Start

December 21, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Due to patients data privacy

Locations