GCF Bax and Bcl-xl Levels in Periodontitis

NCT06443372 | Completed

• 1 other identifier: Apoptosis
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Intrinsic apoptosis pathway plays a critical role in the host immune defense and inflammation and its dysregulation is involved in various chronic diseases. Bcl-2 protein family primarly mediates this mitochondrial pathway. This study aimed to investigate the pro-apoptotic Bax and anti-apoptotic Bcl-xl levels and their association with interleukin-22 (IL-22) and transforming growth factor-beta 1 (TGF-β1) in gingival crevicular fluid (GCF) of patients with periodontitis. In total 75 systemically healthy and non-smoker individuals consisting of stage III periodontitis (n=23), gingivitis (n=26), periodontally healthy (n=26) were enrolled. Whole-mouth clinical periodontal measurements were recorded. Bax, Bcl-xl, IL-22 and TGF-β1 levels in GCF were determined by ELISA. Data were analyzed using non-parametric statistical tests.

Conditions

Periodontitis; Gingivitis; Periodontal Health

Outcome Measures

Primary Outcomes (2)

• GCF Bax levels

  Total amounts (ng)

  24 hours after clinical periodontal measurements

• GCF Bcl-xl levles

  Total amounts (ng)

  24 hours after clinical periodontal measurements

Secondary Outcomes (2)

• GCF IL-22 levels

  24 hours after clinical periodontal measurements

• GCF TGF-β1 levels

  24 hours after clinical periodontal measurements

Study Arms (3)

Periodontitis

Periodontitis group (n = 23, generalized stage III) had interproximal CAL≥5 mm, along with PD≥6 mm and RBL extending to the mid-third of the root or beyond at 30% of the teeth or more. CAL was not originated from endodontic lesions draining through the marginal periodontium, dental caries extending into the cervical areas of the teeth, trauma-related gingival recession or distal bone loss in 2nd molars owing to extractions of 3rd molars. They had ≤4 teeth lost due to periodontitis.

Other: Clinical periodontal measurements, GCF sampling

Gingivitis

Gingivitis group (n = 26) exhibited PD was ≤3 mm and BOP was ≥30% in the entire mouth as well as no detectable interproximal CAL or RBL.

Other: Clinical periodontal measurements, GCF sampling

Periodontal Health

Periodontally healthy controls (n = 26) had clinically healthy gingiva on intact periodontium with PD ≤3 mm and BOP \<10% and without detectable interproximal CAL and RBL.

Other: Clinical periodontal measurements, GCF sampling

Interventions

Clinical periodontal measurements, GCF sampling OTHER

Clinical periodontal measuements included PD, CAL, BOP (+/-), GI, and PI. Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars. GCF samples were obtained 1 day following the clinical measurements. GCF was sampled with paper strips from two deepest pockets in periodontitis group; the most inflamed sites with clinical signs of redness or edema in gingivitis group; and the sites without visible inflammation in periodontally healthy group. GCF and saliva samples were stored at -80 °C until further analysis.

Gingivitis; Periodontal Health; Periodontitis

Eligibility Criteria

• Age: 27 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This prospective case-control study consecutively enrolled 75 individuals (36 males and 39 females; aged 27 to 48 years; mean age, 37.30 ± 5.10 years) from the Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University, Aydın, Turkey, in the period from March 2019 to January 2020.

You may qualify if:

• No history of smoking
• At least 18 natural teeth (excluding 3rd molars)

You may not qualify if:

• Being diagnosed with diabetes mellitus, rheumatoid arthritis, cardiovascular system diseases, endocrine, immunologic, and mucocutaneous disorders
• Use of antibiotics, antihypertensives immunosuppressive and anti-inflammatory drugs within the past 6 months and topical antiseptic solutions in the last 3 months
• Having periodontal treatment in the previous year
• Wearing removable partial dentures or orthodontic appliances
• Restorative and endodontic therapy requirements
• Pregnant or nursing women

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Beral Afacan

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: March 22, 2019
• Primary Completion: January 27, 2020
• Study Completion: April 12, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

TU (1)