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

NCT05449093 | Completed

• 1 other identifier: bafacan0922
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Periodontal Inflammation

Outcome Measures

Primary Outcomes (2)

• Gingival crevicular fluid Galectin-3 levels

  ng

  24 hours after clinical periodontal measurements

• Gingival crevicular fluid interleukin-1 beta levels

  pg

  24 hours after clinical periodontal measurements

Study Arms (4)

Stage 3 Grade C Periodontitis

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.

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Stage 3 Grade B Periodontitis

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.

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Gingivitis

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.

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Periodontal Health

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.

Other: Periodontal clinical measurements and gingival crevicular fluid sampling

Interventions

Periodontal clinical measurements and gingival crevicular fluid sampling OTHER

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.

Gingivitis; Periodontal Health; Stage 3 Grade B Periodontitis; Stage 3 Grade C Periodontitis

Eligibility Criteria

• Age: 25 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 80 systemically healthy and non-smoker individuals (36 males and 44 females) aged 25-52 years were consecutively included.

You may qualify if:

• Non-smokers with no history of smoking (determined by self-reporting)
• Individuals who had at least 20 teeth (excluding third molars)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University, Faculty of Dentistry, Department of Periodontology

Aydin, 09100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Beral Afacan

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

• Gülnur Emingil

  İzmir Ege University

  STUDY DIRECTOR

• Harika Atmaca İlhan

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

• Timur Köse

  İzmir Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: February 21, 2019
• Primary Completion: August 23, 2019
• Study Completion: September 2, 2019
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)