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

Aydin Adnan Menderes University

Status: Completed

Conditions: Periodontitis; Periodontal Inflammation

Treatments: Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05449093

bafacan0922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 25 to 52 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Stage 3 Grade C Periodontitis

Description:

Generalized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that clinical attachment loss was caused by periodontal causes. These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. If this value was higher than 1.0, the patients were assigned to grade C.

Treatment:

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Stage 3 Grade B Periodontitis

Description:

Generalized stage 3 periodontitis patients had interproximal clinical attachment loss ≥ 5 mm at 30 % of the teeth or more. Care was taken to ensure that CAL was caused by periodontal causes.These patients had also radiographic bone loss extending to the mid-third of the root or beyond and probing depth ≥ 6 mm at 30 % of the teeth or more as well as Class II-III furcation involvement. The grade of periodontitis was estimated with indirect evidence of progression through % of bone loss/age. Radiographic bone loss of each natural tooth was assessed by using the panoramic radiograph. The tooth showing the most extensive bone loss was determined and % of bone loss/age were calculated. When this value was between 0.25 and 1.0, patients were included in grade B.

Treatment:

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Gingivitis

Description:

Gingivitis patients showed probing depth ≤ 3 mm with bleeding on probing ≥ 30 % in the entire mouth as well as no interproximal clinical attachment loss or radiographic bone loss.

Treatment:

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Periodontal Health

Description:

Periodontally healthy individuals in the control group had an intact periodontium or a reduced periodontium (without detectable interproximal clinical attachment loss or radiographic bone loss) in a non-periodontitis patient. In this group, probing depth was ≤ 3 mm and bleeding on probing was \< 10 % in the whole mouth.

Treatment:

Other: Periodontal clinical measurements and gingival crevicular fluid sampling