The Efficacy of Scaling and Root Planing on Endothelin-1 Level (clinical)

January 15, 2025 updated by: Sarah Alrihaymee, University of Baghdad

The Efficacy of Scaling and Root Planing on Endothelin-1 Gingival Crevicular Fluid Levels Among Periodontitis Patients: a Randomized Clinical Trial

Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.

Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.

Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Periodontitis is a chronic inflammatory disease resulting from bacterial invasion. Endothelin (ET-1) is a potent vasoconstrictor critical in the pathophysiology of periodontal diseases.

Aim The present study aimed to measure the ET-1 concentrations in gingival crevicular fluid (GCF) at baseline, one and three months subsequently to non-surgical periodontal therapy.

Material and methods Designed as a clinical trial, 24 periodontitis individuals will be voluntarily consented to participate. Following non-surgical periodontal treatment, GCF samples will be collected to determine the amount of endothelin-1 at baseline, one, and three months. Clinical periodontal parameters will be recorded.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • systemically healthy
  • Generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm)

Exclusion Criteria:

  • subjects who wore dental prosthesis
  • teeth with grade II mobility,
  • alcoholic and smoker, had treated caries
  • underwent periodontal therapy within the last four months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: have generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm).
got generalized unstable periodontitis with a moderately deep pocket (4,5 or 6 mm) will undergo scaling and root surface debritment
Device: Scaling and root surface debritment
Patients with 4-6 mm pocket depth were participated in this study; clinical periodontal parameters (BOP, PLI, PPD, CAL) were recorded at the baseline visit. To ensure sampling accuracy, From the site two papers with GCF were sampled. Following sample collecting for GCF, Every patient received comprehensive mouth supragingival scaling with an ultrasonic scaler (WoodpEEKer® UDS-K) along with dental hygiene recommendations. One week later, the sites were irrigated with normal saline after being scaled and root planed (ScRp) with Gracey curette. Following completion of subgingival instrumentation, each patient returned to the clinic following 1 and 3 months for periodontal parameter recording and GCF collection. Throughout these sessions, every patient received reinstruction to engage in self-oral hygiene practices.
Other Names:
  • Scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPD
Time Frame: 3 months recall visits
changes in PPD after non-surgical periodontal treatment.
3 months recall visits
CAL
Time Frame: 3 months recall visits
changes in CAL after non-surgical periodontal treatment.
3 months recall visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ET-1
Time Frame: 3 months recall visits
change in GCF level of Endothelin-1 in 1- and 3- month following the periodontal treatment
3 months recall visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/10/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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