Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation

January 21, 2023 updated by: Zahi BADRAN, University of Sharjah

Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease.

There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health.

And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Control group : Patients diagnosed as periodontally healthy

  • Test group:

    • Patients diagnosed with generalized periodontitis (Stage 3/4, Grade a,b or c).
    • Having at least 15 remaining teeth.
    • Mentally able to understand the communication and to express an informed consent

Exclusion Criteria:

  • Systemic diseases with known effect on periodontal health
  • Antibiotics/Anti-inflammatory drugs taken in the last month
  • Women with suspected/known pregnancy, or taking any hormone-based treatment
  • Patients suffering from Xerostomia.
  • Patients smoking more than 20 cig/day.
  • Previous periodontal therapy in the last 3-6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy
Procedure: Non surgical periodontal therapy
Manual root planning+Ultrasonic subgingival debridement
No Intervention: Control
Periodontally healthy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoxin A4
Time Frame: 2 months
Gingival crevicular fluid concentration
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sharjah

Investigators

  • Study Director: Prof. Zahi Badran, Phd, University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 21, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-22-02-28-02-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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