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Clinical Trials/NCT05994885
NCT05994885RecruitingNot Applicable

Prognostic Potentials of E-cadherin and Total Antioxidant Capacity in Gingival Crevicular Fluid of Moderately Deep Periodontal Pockets Treated With Nonsurgical Periodontal Therapy

Ali A Abdulkareem1 site in 1 country20 target enrollmentStarted: February 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Probing pocket depth

Study Overview

Brief Summary

Ability to anticipate the outcomes of periodontal therapy at baseline visit is crucial to outline and customize a treatment plan with predictable outcomes and cost-effectiveness. Presence of diverse range of health/disease-associated molecules in oral environment that reflect health and disease, together with clinical parameters, is an appealing approach to use them as biomarkers to diagnose, predict, and monitor periodontal disease. Among these proteins are E-cad and TAC which available evidence indicate that their concentrations in oral biofluids increase remarkably during periodontitis as compared to healthy periodontium.

Detailed Description

Loss of attachment and formation of periodontal pockets are hallmarks of periodontitis. The treatment approach is either by nonsurgical or surgical periodontal therapy or a combination of both depending on the severity of the case. In general, sites with moderately deep pockets (4 to 6 mm) are responding favorably to nonsurgical periodontal therapy (NSPT). Nevertheless, some sites exhibit persistent pockets even with multiple treatment sessions which could be attributed to the presence of tissue invaders or aberrant immune response that impede healing process.

Prediction of treatment outcomes based on clinical data is limited and sometimes lacking accuracy. Use of biomarkers that can be non-invasively collected from oral fluids e.g., gingival crevicular fluid (GCF) as diagnostic/predictive tools has gained attention in the last decade. For instance, E-Cadherin (E-cad) and total antioxidant capacity (TAC) are associated with periodontitis. E-cad is a transmembrane glycoprotein that is a key mediator of stable cell-cell adhesion of epithelial cells. E-cadherin-based adherens junctions specialized cell structures that mediate cell-cell adhesion and regulate cytoskeleton reorganization forming a continuous, linear circumferential belt (zonula adherens) around the apical part of the cell. While TAC, defined as the moles of oxidants neutralized by one liter of solution, is a biomarker measuring the antioxidant potential of body fluids.

Available evidence indicates that the concentration of both molecules are substantially increased with increasing severity of periodontitis and vice versa in periodontal health. This suggests the potential of GCF-E-cad and TAC to predict the prognosis following NSPT.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Masking Description

The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Systemically healthy adult patients (> 18 years).
  • Periodontitis (interdental clinical attachment loss (CAL) detectable at ≥2 non-adjacent teeth, or buccal/oral CAL of ≥3mm with pocketing of >3mm is detectable at ≥2 teeth). All patients should exhibit generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C. Only maxillary teeth with single root will be included.

Exclusion Criteria

  • Consumption of antibiotics or periodontal treatment 3-months prior to the study.
  • Pregnancy and lactation.
  • History of systemic disease e.g., diabetes mellitus.
  • Patients currently recruited in other trials.
  • Patients not willing to consent.
  • Periodontal pockets ≥ 7mm, active caries, endodontic problem.
  • Multi-rooted teeth will be also considered as exclusion reasons.

Outcomes

Primary Outcomes

Probing pocket depth

Time Frame: Baseline, 1 week, then 1 month and 3 months after treatment

Linear distance, in mm, measured from the gingival margin to the base of periodontal pocket or sulcus.

Secondary Outcomes

  • Clinical attachment loss(Baseline, 1 week, then 1 month and 3 months after treatment)
  • Bleeding on probing(Baseline, 1 week, then 1 month and 3 months after treatment)
  • Total antioxidant capacity(Baseline, 1 month and 3 months after treatment)
  • Gingival crevicular fluid E-cadherin(Baseline, 1 month and 3 months after treatment)

Investigators

Sponsor
Ali A Abdulkareem
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ali A Abdulkareem

Assistant Professor

University of Baghdad

Study Sites (1)

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