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

NCT05706675 | Unknown

• 1 other identifier: REC-22-02-28-02-S
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Lipoxin A4

  Gingival crevicular fluid concentration

  2 months

Study Arms (2)

Experimental

EXPERIMENTAL

Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy

Procedure: Non surgical periodontal therapy

Control

NO INTERVENTION

Periodontally healthy patients

Interventions

Non surgical periodontal therapy PROCEDURE

Manual root planning+Ultrasonic subgingival debridement

Experimental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University Dental Hospital Sharjah

Sharjah city, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Inflammation; Periodontitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Prof. Zahi Badran, Phd

  University of Sharjah

  STUDY DIRECTOR

Central Study Contacts

Prof. Zahi BADRAN, PhD

CONTACT

+97165057353; zbadran@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 31, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)