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Oral and Systemic Levels of TFF-1 and TTF-3 in Periodontal Diseases

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ClinicalTrials.gov Identifier: NCT04407026
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Zeynep Pinar KELES YUCEL, Giresun University

Tracking Information
First Submitted Date May 25, 2020
First Posted Date May 29, 2020
Last Update Posted Date May 29, 2020
Actual Study Start Date July 1, 2017
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2020)
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels [ Time Frame: one day after the clinical periodontal measurements ]
Gingival crevicular fluid, saliva and serum TFF-1 and TFF-3 levels of gingivitis and periodontitis patients as well as healthy individuals were analyzed to identify the potential role of these peptides in periodontal diseases.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Gingival crevicular fluid, saliva and serum
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.
Condition Periodontal Diseases
Intervention Biological: biofluids
Gingival crevicular fluid, saliva and serum samples were obtained.
Study Groups/Cohorts
  • Healthy
    Healthy control group (n=25) consisted of the volunteers having clinically healthy gingiva, PD≤3 mm, BOP<10% and no sign of clinical attachment loss and radiographic alveolar bone destruction.
    Intervention: Biological: biofluids
  • Gingivitis
    Gingivitis group (n=25) had PD≤3 mm with BOP>50% in the entire mouth, and no clinical attachment loss or alveolar bone loss.
    Intervention: Biological: biofluids
  • Stage 3 periodontitis
    Stage 3 periodontitis group included the patients exhibiting PD ≥6 mm and interdental CAL ≥5 mm at %30 or more teeth. They had no more than four teeth loss.
    Intervention: Biological: biofluids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2020)
100
Original Actual Enrollment Same as current
Actual Study Completion Date April 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04407026
Other Study ID Numbers 2017/009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zeynep Pinar KELES YUCEL, Giresun University
Study Sponsor Aydin Adnan Menderes University
Collaborators Not Provided
Investigators
Principal Investigator: Zeynep Pinar Keles Yucel Giresun University
PRS Account Aydin Adnan Menderes University
Verification Date May 2020