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Evaluation of Prognostic Potentials of Gingival Crevicular Fluid E-cadherin and Total Antioxidant Capacity

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Root surface debridement
Sponsored by
Ali A Abdulkareem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • College of Dentistry/ University of BaghdadRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Root surface debridement

Arm Description

Periodontal pockets with PPD of 4 to 6mm are treated with root surface debridement only and assessed after 3 months for success/failure of treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical attachment loss
Linear distance, in mm, measured from the cementoenamel junction to the base of periodontal pocket or sulcus.
Bleeding on probing
Presence or absence of bleeding is detected after 30 seconds of inserting periodontal probe to the depth of periodontal pocket/sulcus
Gingival crevicular fluid E-cadherin
Level of E-cadherin in GCF collected from periodontal pockets is determined by biochemical analysis
Total antioxidant capacity
Level of TAC in GCF collected from periodontal pockets is determined by biochemical analysis

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
Ali A Abdulkareem
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1. Study Identification

Unique Protocol Identification Number
NCT05994885
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali A Abdulkareem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with periodontitis, of any stage, having periodontal pockets of a moderate depth (4 to 6 mm) treated with nonsurgical periodontal therapy.
Masking
None (Open Label)
Masking Description
The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Root surface debridement
Arm Type
Other
Arm Description
Periodontal pockets with PPD of 4 to 6mm are treated with root surface debridement only and assessed after 3 months for success/failure of treatment.
Intervention Type
Procedure
Intervention Name(s)
Root surface debridement
Intervention Description
the included patients will undergo full-mouth supra- and subgingival debridement by using ultrasonic device and manual instrumentation at baseline. This is followed, after 1 week, by performing root surface debridement for all pockets with PPD = 4-6 mm for each patient. All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.
Primary Outcome Measure Information:
Title
Probing pocket depth
Description
Linear distance, in mm, measured from the gingival margin to the base of periodontal pocket or sulcus.
Time Frame
Baseline, 1 week, then 1 month and 3 months after treatment
Secondary Outcome Measure Information:
Title
Clinical attachment loss
Description
Linear distance, in mm, measured from the cementoenamel junction to the base of periodontal pocket or sulcus.
Time Frame
Baseline, 1 week, then 1 month and 3 months after treatment
Title
Bleeding on probing
Description
Presence or absence of bleeding is detected after 30 seconds of inserting periodontal probe to the depth of periodontal pocket/sulcus
Time Frame
Baseline, 1 week, then 1 month and 3 months after treatment
Title
Gingival crevicular fluid E-cadherin
Description
Level of E-cadherin in GCF collected from periodontal pockets is determined by biochemical analysis
Time Frame
Baseline, 1 month and 3 months after treatment
Title
Total antioxidant capacity
Description
Level of TAC in GCF collected from periodontal pockets is determined by biochemical analysis
Time Frame
Baseline, 1 month and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali A Abdulkareem, PhD
Phone
07806866717
Email
ali.abbas@codental.uobaghdad.edu.iq
Facility Information:
Facility Name
College of Dentistry/ University of Baghdad
City
Baghdad
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali A Abdulkareem, PhD
Phone
009647806866717
Email
ali.abbas@codental.uobaghdad.edu.iq

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Prognostic Potentials of Gingival Crevicular Fluid E-cadherin and Total Antioxidant Capacity

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