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Completed

NCT Number: NCT06110221

Activin-A and Interleukin-1β Levels in Periodontitis

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.

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Key information

Age range

27 year–48 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

About this study

Participants were divided into three groups according to the diagnostic criteria proposed by the Classification of Periodontal and Peri-implant Diseases and Conditions; I. Periodontitis group (n=23), II. Gingivitis group (n=26) III. Periodontally healthy group (n=26)

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/mesiolingual, palatal/lingual, and distopalatal/distolingual) of all teeth, except the 3rd molars, by a single investigator using a conventional periodontal probe.

Interproximal radiographic bone loss on the digital panoramic radiographs were evaluated, as the ratio of the distance between the bone crest and the cemento-enamel junction to the length of the root.

GCF and unstimulated whole saliva samples were obtained 1 day following the clinical periodontal measurements. Immediately after saliva collection, GCF was collected from the buccal aspects of non-contiguous interproximal sites in two single-rooted teeth via steril paper strips. Fluid samples were obtained from two deepest pockets in periodontitis group and the most inflamed sites with clinical signs of redness or edema in gingivitis group. In the periodontally healthy groups, samples were taken from the sites without visible inflammation. All samples were stored at -80 °C until further analysis.

Measurement of Activin-A and IL-1β levels in GCF and saliva samples were performed by the commercially available enzyme-linked immunosorbent assay (ELISA) kits. While GCF cytokine levels were expressed as both total amounts at two samples per 30 s and concentrations, salivary cytokine levels were presented as concentrations.

A statistical software package was used for all data analyses. If the clinical and biochemical data did not present normal distribution as checked by Shapiro Wilk's normality test, the analyses were performed by using nonparametric methods. The Kruskal-Wallis test with Dunn-Bonferroni post hoc method was applied to compare the study groups regarding clinical indices and oral biofluid levels of Activin-A and IL-1β. The presence and degree of linear association of cytokine levels in GCF and saliva with clinical indices were analyzed by Spearman rank correlation coefficient. p<0.05 was considered as a threshold for statistical significance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. GCF Activin-A levels

    Time frame: 24 hours after clinical periodontal measurements

    total amount (ng)

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Oral Biofluid Levels of Activin-A and Interleukin-1 Beta Levels in Periodontal Health and Disease

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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