Clinical trial NCT05994885: Evaluation of Prognostic Potentials of Gingival Crevicular Fluid E-cadherin and Total Antioxidant Capacity
Official title: Prognostic Potentials of E-cadherin and Total Antioxidant Capacity in Gingival Crevicular Fluid of Moderately Deep Periodontal Pockets Treated With Nonsurgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with periodontitis, of any stage, having periodontal pockets of a moderate depth (4 to 6 mm) treated with nonsurgical periodontal therapy.
Primary purpose: OTHER

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.

Eligibility criteria: 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.
* Smoker.
* 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.

Primary outcomes:
measure: Probing pocket depth
timeFrame: Baseline, 1 week, then 1 month and 3 months after treatment
Secondary outcomes:
measure: Clinical attachment loss
timeFrame: Baseline, 1 week, then 1 month and 3 months after treatment
measure: Bleeding on probing
timeFrame: Baseline, 1 week, then 1 month and 3 months after treatment
measure: Gingival crevicular fluid E-cadherin
timeFrame: Baseline, 1 month and 3 months after treatment
measure: Total antioxidant capacity
timeFrame: Baseline, 1 month and 3 months after treatment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry/ University of Baghdad
Study officials:
References: