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

Primary Purpose

Inflammation, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Non surgical periodontal therapy
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Dental Hospital SharjahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy

Periodontally healthy patients

Outcomes

Primary Outcome Measures

Lipoxin A4
Gingival crevicular fluid concentration

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
January 21, 2023
Sponsor
University of Sharjah
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1. Study Identification

Unique Protocol Identification Number
NCT05706675
Brief Title
Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
Official Title
Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Periodontally healthy patients
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal therapy
Intervention Description
Manual root planning+Ultrasonic subgingival debridement
Primary Outcome Measure Information:
Title
Lipoxin A4
Description
Gingival crevicular fluid concentration
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Zahi BADRAN, PhD
Phone
+97165057353
Email
zbadran@sharjah.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Zahi Badran, Phd
Organizational Affiliation
University of Sharjah
Official's Role
Study Director
Facility Information:
Facility Name
University Dental Hospital Sharjah
City
Sharjah
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahi BADRAN
Email
zbadran@sharjah.ac.ae

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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