Activin-A and Interleukin-1β Levels in Periodontitis

NCT06110221 | Completed

• 1 other identifier: Activin-A
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Activin-A belongs to the transforming growth factor-beta superfamily and is a multifunctional cytokine that plays a role in inflammation, immune response, tissue repair and regeneration. Proinflammatory cytokine interleukin-1beta (IL-1β) can increase Activin-A expression in various cell types. This study aims to evaluate gingival crevicular fluid (GCF) and salivary Activin-A and IL-β levels in stage III periodontitis. Seventy-five systemically healthy and non-smoker volunteers consisting of 23 stage III periodontitis, 26 gingivitis and 26 periodontally healthy were enrolled. Full-mouth clinical periodontal indices were recorded, unstimulated whole saliva and GCF samples were obtained, Activin-A and IL-1β total amounts were determined by enzyme-linked immunosorbent assay. Statistical comparisons were performed using non-parametric tests.

Conditions

Periodontitis; Gingivitis; Periodontal Health

Outcome Measures

Primary Outcomes (1)

• GCF Activin-A levels

  total amount (ng)

  24 hours after clinical periodontal measurements

Study Arms (3)

Periodontitis

This group consisted of patients with generalized stage III periodontitis, who had interproximal CAL≥5 mm and PD≥6 mm as well as radiographical bone loss extending to the mid-third of the root or beyond at 30% of the teeth or more. CAL was not caused by trauma-related gingival recession, dental caries extending into the cervical areas of the teeth, endodontic lesions draining through the marginal periodontium, and the distal bone loss in adjacent second molars due to extractions of third molars. They showed no more than four teeth loss due to periodontitis.

Other: Periodontal clinical measurements, GCF and saliva sampling

Gingivitis

This group demonstrated no detectable interproximal CAL or radiographical bone loss. PD was ≤3 mm and BOP (%) was ≥30% in the entire mouth.

Other: Periodontal clinical measurements, GCF and saliva sampling

Periodontal health

This healthy control group had an intact periodontium without detectable CAL and radiographical bone loss. PD was ≤3 mm and BOP (%) was \<10% in the entire mouth.

Other: Periodontal clinical measurements, GCF and saliva sampling

Interventions

Periodontal clinical measurements, GCF and saliva sampling OTHER

Clinical periodontal indices included probing depth (PD), clinical attachment loss (CAL), the dichotomous scoring of bleeding on probing (BOP +/-), gingival index (GI), and plaque index (PI). Clinical recordings were performed at six points (mesiobuccal, buccal, distobuccal, mesiopalatal, palatal, and distopalatal) of all teeth, except the 3rd molars. GCF and saliva samples were obtained 1 day following the clinical measurements. Unstimulated whole saliva was collected from all participants. 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 (39 females and 36 males and; 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:

• the presence of no history of smoking (determined by self-reporting)
• at least 18 natural teeth excluding 3rd molars.

You may not qualify if:

• the presence of systemic conditions (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)

Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid and saliva

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Beral Afacan

  Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University

  PRINCIPAL INVESTIGATOR

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: Assoc. Prof.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: March 22, 2019
• Primary Completion: January 27, 2020
• Study Completion: February 2, 2020
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

TU (1)