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

NCT05994885 | Unknown

• 1 other identifier: 747622
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth

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

  Baseline, 1 week, then 1 month and 3 months after treatment

Secondary Outcomes (4)

• 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

• Gingival crevicular fluid E-cadherin

  Baseline, 1 month and 3 months after treatment

• Total antioxidant capacity

  Baseline, 1 month and 3 months after treatment

Study Arms (1)

Root surface debridement

OTHER

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.

Procedure: Root surface debridement

Interventions

Root surface debridement PROCEDURE

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.

Root surface debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali A Abdulkareem: lead

Study Sites (1)

College of Dentistry/ University of Baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Ali A Abdulkareem, PhD

CONTACT

07806866717; ali.abbas@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients with periodontitis, of any stage, having periodontal pockets of a moderate depth (4 to 6 mm) treated with nonsurgical periodontal therapy.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: February 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 25, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)