GCF PLAP-1, Sclerostin and TNF-α Levels in Periodontitis

NCT05656989 | Completed

• 1 other identifier: PLAP-1
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal ligament-associated protein-1 (PLAP-1) and sclerostin play an important role in the suppression of bone formation. Tumor necrosis factor-alpha (TNF-α) is an important proinflammatory cytokine involved in periodontal bone loss. This study aims to investigate gingival crevicular fluid (GCF) PLAP-1, sclerostin and TNF-α levels in individuals with periodontal disease. Totally 71 systemically healthy and non-smoker individuals consisting of stage 3 grade C periodontitis (n=23), gingivitis (n=24) and periodontally healthy (n=24) were enrolled. Periodontal status was evaluated by measuring the full-mouth clinical periodontal parameters. GCF PLAP-1, sclerostin and TNF-α total amounts were measured by ELISA. Data were analyzed using non-parametric statistical tests.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

• GCF PLAP-1 levels

  ng

  24 hours after clinical periodontal measurements

• GCF sclerostin levels

  ng

  24 hours after clinical periodontal measurements

• GCF TNF-α levels

  ng

  24 hours after clinical periodontal measurements

Study Arms (3)

Stage 3 Grade C Periodontitis

Generalized S3GC periodontitis patients had PD ≥ 6 mm and interproximal CAL ≥ 5 mm and with radiographic alveolar bone loss extending at least to the middle third of the root at 30 % of the teeth or more. These patients showed no more than four teeth loss due to periodontitis. The percentage bone loss/age values in this group were \> 1.0

Other: Periodontal clinical measurements and GCF sampling

Gingivitis

Gingivitis patients exhibited PD ≤ 3 mm and no interproximal CAL or radiographic bone loss. These patients had BOP ≥ 30% of probe sites.

Other: Periodontal clinical measurements and GCF sampling

Periodontal health

Periodontally healthy controls had an intact periodontium or a reduced periodontium in a non-periodontitis patient (without interproximal CAL or radiographic bone loss). PD was ≤ 3 mm and BOP was \< 10 % in this group.

Other: Periodontal clinical measurements and GCF sampling

Interventions

Periodontal clinical measurements and GCF sampling OTHER

Periodontal clinical parameters measurements probing depth (PD), clinical attachment loss (CAL), the dichotomous recording (present/absent) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were recorded at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth, except the third molars using a manual periodontal probe. A sterile paper strip was gently placed into the gingival sulcus/periodontal pocket until mild resistance was sensed and left in place for 30 seconds.

Gingivitis; Periodontal health; Stage 3 Grade C Periodontitis

Eligibility Criteria

• Age: 27 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 71 systemically healthy and never-smoker individuals (34 males and 37 females and; aged 27 to 46 years) were consecutively included for this cross-sectional study.

You may qualify if:

• no history of smoking (determined by self-reporting)
• had a minimum of 18 natural remaining teeth (excluding third molars).

You may not qualify if:

• suffered from diabetes mellitus, rheumatoid arthritis, cardiovascular and respiratory system diseases, hepatic and renal failure, metabolic bone diseases, endocrine disorders, immunologic and mucocutaneous diseases
• used immunosuppressive agents, antibiotics, anti-inflammatory and anti-resorptive drugs, topical antiseptic solutions, calcium channel blockers, beta-blockers, anticoagulants and hormonal contraceptives within the past 3 months
• pregnant or lactating
• received any periodontal intervention in the past year
• used removable partial dentures or orthodontic appliances

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

• Gur B, Afacan B, Cevik O, Kose T, Emingil G. Gingival crevicular fluid periodontal ligament-associated protein-1, sclerostin, and tumor necrosis factor-alpha levels in periodontitis. J Periodontol. 2023 Oct;94(10):1166-1175. doi: 10.1002/JPER.22-0750. Epub 2023 Apr 19.

  PMID: 37006132 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berkay Gür

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

• Özge Çevik

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

• Timur Köse

  İzmir Ege University

  PRINCIPAL INVESTIGATOR

• Gülnur Emingil

  İzmir Ege University

  PRINCIPAL INVESTIGATOR

• Beral Afacan

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 20, 2022
• Study Start: September 20, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 15, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

TU (1)