Clinical trial NCT04407026: Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases
Official title: Two Novel Peptides Associated With Stage 3 Periodontitis: TFF-1 and TFF-3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy controls included volunteers with clinically healthy periodontium who had BOP \< 10% and PD ≤ 3 mm, no sites with attachment loss or radiographic sign of alveolar bone destruction. Gingivitis patients showed PD ≤ 3 mm with BOP \> 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Stage 3) had PD ≥ 6 mm, interdental CAL ≥ 5 mm affecting 30% of the teeth or more and showed radiographic bone loss. They showed also no more than 4 teeth loss due to periodontitis.

Brief summary: Trefoil factor family (TFF) consists of a group of small peptides that have key roles in host immune response and repair of tissue damage. Interleukin (IL)-1β is a regulatory proinflammatory cytokine in periodontal inflammation. This study aimed to investigate the levels of TFF-1, TFF-3 and IL-1β in gingival crevicular fluid (GCF), saliva and serum of patients with gingivitis, stage 3 periodontitis and healthy individuals.

Detailed description: A total of one hundred participants were enrolled for the study. All individuals were assessed clinically and radiographically. Full-mouth clinical periodontal examinations were performed by the measurements of probing depth (PD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and bleeding on probing (BOP). All these measurements were recorded at six sites around each tooth with a manual periodontal probe. The participants were categorized into three groups: healthy controls (n=25), patients with gingivitis (n=25) and patients with periodontitis (n=50). Gingival crevicular fluid, saliva and serum samples were collected from each participant one day after the clinical periodontal measurements. TFF-1, TFF-3 and IL-1β levels of these biofluids were determined using the enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals
* No history of smoking
* Individuals between the ages of 25-50 years
* Having at least 20 natural teeth

Exclusion Criteria:

* Any systemic disorders (i.e. diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological disorders, collagen-metabolic diseases, cancer)
* A history of smoking
* Pregnancy or lactation
* A history of surgical/non-surgical periodontal therapy in the past 1 year
* Drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) in the previous 6 months

Primary outcomes:
measure: Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels
timeFrame: one day after the clinical periodontal measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Zeynep Pinar Keles Yucel
Study officials:
affiliation: Giresun University
name: Zeynep Pinar Keles Yucel
role: PRINCIPAL_INVESTIGATOR
References: