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

Sponsor

University of Sharjah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05706675

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Periodontitis	Procedure: Non surgical periodontal therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Lipoxin A4 [2 months]
Gingival crevicular fluid concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Dental Hospital Sharjah	Sharjah		United Arab Emirates

Sponsors and Collaborators

University of Sharjah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahi BADRAN, Professor, University of Sharjah

ClinicalTrials.gov Identifier:

NCT05706675

Other Study ID Numbers:

REC-22-02-28-02-S

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Inflammation

Study Results

No Results Posted as of Jan 31, 2023