GCF Annexin-A1, Carbonic Anhydrase-1, and Elongation Factor-1 Gamma Levels in Periodontitis

NCT05680441 | Completed

• 1 other identifier: CANSU35
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to investigate gingival crevicular fluid (GCF) levels of possible novel biomarkers Annexin-A1 (ANX A1), Carbonic anhydrase- 1 (CA I), and Elongation Factor-1 Gamma (EF1-Ɣ) in health along with different periodontal diseases. In total, 80 systemically healthy individuals were included in this study; 20 with periodontitis stage 3 grade B , 20 with periodontitis stage 3 grade C (P-Stage III/C), 19 with gingivitis, and 21 with clinically healthy periodontium. Probing depth, clinical attachment level, plaque index, and papillary bleeding index were recorded. GCF ANX A1, CA I and EF1-Ɣ levels were analyzed by enzyme-linked immunosorbent assay (ELISA). Receiver operating characteristics curve was used for estimating the under the curve.

Conditions

Periodontitis; Periodontal Inflammation

Outcome Measures

Primary Outcomes (3)

• Gingival crevicular fluid Annexin-A1 levels

  ng

  24 hours after clinical periodontal measurements

• Gingival crevicular fluid Carbonic Anhydrase-1 levels

  ng

  24 hours after clinical periodontal measurements

• Gingival crevicular fluid Elongation Factor-1 Gamma- Ɣ levels

  ng

  24 hours after clinical periodontal measurements

Study Arms (4)

Healty group

The controls/Healthy group were the individuals with well-maintained oral hygiene without no periodontal disease history or symptoms with a probing pocket depth (PPD) of ≤3 mm and bleeding on probing (BOP) of (+) ≤10.

Other: Peirodontal clinical measurements and gingival crevicular fluid sampling

Periodontitis stage 3 grade B

Stage III periodontitis patients had at least 4 interdental sites clinical attachment level (CAL)\> 5 mm due to periodontitis, radiographic bone loss reaching to the mid-third of the root or beyond, teeth loss less than 4 teeth due to periodontitis. These patients were graded according to the bone loss%/age index (Grade B, 0.25-1.00).

Other: Peirodontal clinical measurements and gingival crevicular fluid sampling

Periodontitis stage 3 grade C

Stage III periodontitis patients had at least 4 interdental sites clinical attachment level (CAL)\> 5 mm due to periodontitis, radiographic bone loss reaching to the mid-third of the root or beyond, teeth loss less than 4 teeth due to periodontitis.Since the bone loss (%)/age values were \>1.0, all periodontitis patients were considered grade C.

Other: Peirodontal clinical measurements and gingival crevicular fluid sampling

Gingivitis

Only generalized gingivitis patients were included in this study. Individuals presenting with a BOP≥30% and PPD≤3 mm without radiographic bone loss and attachment loss were considered to have gingivitis.

Other: Peirodontal clinical measurements and gingival crevicular fluid sampling

Interventions

Peirodontal clinical measurements and gingival crevicular fluid sampling OTHER

The clinical periodontal examination of the healthy and periodontitis subjects consisted of plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP) recorded. CAL was calculated by adding GR to the PPD values. Averages for full mouth PPD, CAL, and the percentage of sites with BOP were calculated for each subject. A single calibrated examiner (VO) conducted a full mouth periodontal examination of all participants.

Gingivitis; Healty group; Periodontitis stage 3 grade B; Periodontitis stage 3 grade C

Eligibility Criteria

• Age: 20 Years - 61 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(39 males, 41 females) aged 20-61 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(exclude wisdom teeth)

You may not qualify if:

• Pregnant and lacting women
• 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 6 monthsi topical antiseptic solutions in the last 3 months.
• Patients with diagnosed medical illness such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, immunological diseases.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University, Faculty of Dentistry, Department of Periodontology

Izmir, 35340, 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

• Bilge Cansu Uzun Saylan

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Veli Özgen Öztürk

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

• Harika Atmaca İlhan

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

• Gülnur Emingil

  Ege University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 11, 2023
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 16, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

TU (1)