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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706675
• Other study ID #: REC-22-02-28-02-S
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: University of Sharjah
• Contact: Prof. Zahi BADRAN, PhD
• Phone: +97165057353
• Email: zbadran[@]sharjah.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Periodontitis

Intervention

Procedure:
• Non surgical periodontal therapy
Manual root planning+Ultrasonic subgingival debridement

Locations

Country	Name	City	State
United Arab Emirates	University Dental Hospital Sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipoxin A4	Gingival crevicular fluid concentration	2 months