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

NCT ID: NCT05706675

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy

Group Type EXPERIMENTAL

Non surgical periodontal therapy

Intervention Type PROCEDURE

Manual root planning+Ultrasonic subgingival debridement

Control

Periodontally healthy patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Non surgical periodontal therapy

Manual root planning+Ultrasonic subgingival debridement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sharjah

OTHER

Sponsor Role lead

Responsible Party

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Zahi BADRAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. Zahi Badran, Phd

Role: STUDY_DIRECTOR

University of Sharjah

Locations

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University Dental Hospital Sharjah

Sharjah city, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Prof. Zahi BADRAN, PhD

Role: CONTACT

Phone: +97165057353

Email: [email protected]

Facility Contacts

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Zahi BADRAN

Role: primary

Other Identifiers

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REC-22-02-28-02-S

Identifier Type: -

Identifier Source: org_study_id