GCF Galectin-3 and Interleukin-1beta Levels in Periodontitis.

Periodontitis Clinical Trial

Official title:

Gingival Crevicular Fluid Galectin-3 and Interleukin-1beta Levels in Stage 3 Periodontitis With Grade B and C.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449093
• Other study ID #: bafacan0922
• Status: Completed
• Start date: February 21, 2019
• Est. completion date: September 2, 2019

Study information

• Verified date: July 2022
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate gingival crevicular fluid Galectin-3 and Interleukin-1beta levels in different grades (B and C) of stage 3 periodontitis, concurrently, and also to investigate their discriminative efficiencies in periodontal diseases. A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled. Clinical periodontal parameters were recorded and GCF Galectin-3 and interleukin-1 beta total amounts were measured by ELISA. Receiver operating characteristics curve was used for estimating the area under the curve.

Description:

A total of 80 systemically healthy and non-smoker individuals, 20 stage 3 grade C periodontitis 20 stage 3 grade B periodontitis, 20 gingivitis and 20 periodontally healthy were enrolled.

Periodontal clinical measurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed by a graded periodontal probe.

According to the diagnostic criteria proposed by the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions18 participants were classified into four distinct groups based on their periodontal conditions: 1) 20 patients with generalized stage 3 grade C periodontitis; 2) 20 patients with generalized stage 3 grade B periodontitis; 3) 20 patients with gingivitis; and 4) 20 periodontally healthy individuals.

Gingival crevicular fluid was sampled from the buccal aspects of two non-adjacent interproximal sites in single-rooted teeth. Standardized absorbent paper strips were used for sampling. In periodontitis groups, samples were taken from two deepest pockets of single-rooted teeth. Samples were obtained from the sites with visible signs of inflammation in patients with gingivitis and without bleeding on probing in the healthy controls. The absorbed fluid volume was measured by a precalibrated electronic device.

Galectin-3 and interleukin-1 beta levels in gingival crevicular fluids samples were measured by the ELISA via commercial kits in line with the manufacturer's guidelines. Protein concentrations were calculated from the standard curve. Gingival crevicular fluid results for two analytes were expressed as total amounts at two samples per sampling time.

Normality of the data was checked by Shapiro Wilk's normality test. Comparisons of clinical parameters and gingival crevicular fluids biomaker levels among the study groups were performed using Kruskal-Wallis test and Dunn's test (with Bonferroni correction) was used to pairwise comparisons for non-normally distributed variables. Receiver operating characteristic (ROC) curves were constructed to assess the ability of two analytes for diagnosis of periodontitis. Statistical significance was considered at p< 0.05 for all the tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 52 Years

Eligibility

Inclusion Criteria:

• Non-smokers with no history of smoking (determined by self-reporting)

• Individuals who had at least 20 teeth (excluding third molars)

Exclusion Criteria:

• Patients with diagnosed medical illness such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, immunological diseases.

• Patients who under any medication including immunosuppressants, steroids, non-steroidal anti-inflammatory drugs, antibiotics, antiepileptic drugs, calcium channel blockers, beta-blockers, anticoagulants, hormonal contraceptives and nutritional supplements within the past 6 months, topical antiseptic solutions in the last 3 months.

• Pregnant and lactating women

• Individuals who had orthodontic appliances or removable partial dentures

• Individuals who had undergone professional teeth cleaning within the past year

Related Conditions & MeSH terms

• Inflammation
• Periodontal Inflammation
• Periodontitis

Intervention

Other:
• Periodontal clinical measurements and gingival crevicular fluid sampling
Periodontal clinical meaurements including the probing depth, clinical attachment loss, the dichotomous recording (present/absent) of bleeding on probing, gingival index, and the plaque index at six sites (distobuccal, buccal, mesiobuccal, distopalatinal/lingual, palatinal/lingual, mesiopalatinal/lingual) on all teeth, except third molars, were performed using manuel periodontal probe. Standardized absorbent paper strips were used for gingival crevicular fluid sampling. A sterile paper strip was gently inserted into the gingival sulcus/periodontal pocket until mild resistance was felt and were kept in place for 30 seconds. The absorbed fluid volume was measured by a precalibrated electronic device.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University, Faculty of Dentistry, Department of Periodontology	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival crevicular fluid Galectin-3 levels	ng	24 hours after clinical periodontal measurements
Primary	Gingival crevicular fluid interleukin-1 beta levels	pg	24 hours after clinical periodontal measurements