Activin-A and Interleukin-1β Levels in Periodontitis

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Completed
CT.gov ID
NCT06110221
Collaborator
(none)
75
1
10.4
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Periodontal clinical measurements, GCF and saliva sampling

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
75 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Oral Biofluid Levels of Activin-A and Interleukin-1 Beta Levels in Periodontal Health and Disease
Actual Study Start Date :
Mar 22, 2019
Actual Primary Completion Date :
Jan 27, 2020
Actual Study Completion Date :
Feb 2, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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

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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. GCF Activin-A levels [24 hours after clinical periodontal measurements]

    total amount (ng)

Eligibility Criteria

Criteria

Ages Eligible for Study:
27 Years to 48 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aydın Adnan Menderes University Aydın Turkey 09100

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Beral Afacan, Department of Periodontology, School of Dentistry, Aydın Adnan Menderes University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beral Afacan, Assoc. Prof., Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT06110221
Other Study ID Numbers:
  • Activin-A
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023