Periostin and Non-Surgical Periodontal Treatment

April 2, 2020 updated by: Ebru Olgun Erdemir, Kırıkkale University

The Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid Periostin Levels in Patients With Gingivitis and Chronic Periodontitis

A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30 periodontally healthy subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. Gingival crevicular fluid periostin levels were assessed at baseline, at the 6th week and the 3rd month after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Periostin is commonly found in collagen-rich tissues, which is thought to affect the production of collagen fibers. Additionally, periostin is synthesized in tissues exposed to constant mechanical forces such as the periosteum, periodontal ligament, tendon, heart valve and skin. Periostin mediates inflammation and fibrosis during diseases of various organs, including the heart, lung, kidney, skin, liver, skeletal muscle and retina.

This study evaluated periostin levels in gingival crevicular fluid from patients with chronic periodontitis, gingivitis and periodontally healthy as well as the effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic periodontitis
  • Clinical diagnosis of gingivitis
  • Clinical diagnosis of periodontal health

Exclusion Criteria:

  • have any systemic disease
  • to be alcohol consumer
  • to receive any periodontal therapy in the past 6 months
  • to take any drugs regularly
  • to be pregnant and/or lactate

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with chronic periodontitis
Patients with CP (n=30) had teeth with 30% periodontal bone loss and ≥ 2 non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and bleeding on probing.
Procedure: Non-Surgical Periodontal Treatment
Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
Other Names:
  • Initial periodontal therapy
Experimental: Patients with gingivitis
Participants with G (n=30) had gingival index ≥ 2 and other inflammation signs.
Procedure: Non-Surgical Periodontal Treatment
Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
Other Names:
  • Initial periodontal therapy
No Intervention: Participants with periodontal healthy
The H group (n=30) consisted of individuals with no attachment loss, no history of periodontal disease, PD ≤3 mm, and whole-mouth bleeding scores <10%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in periostin
Time Frame: Baseline, 6th week and 3rd month
Total amount of Periostin (pg/30 sec) in gingival crevicular fluid
Baseline, 6th week and 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in periodontal clinical parameter
Time Frame: Baseline, 6th week and 3rd month
Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
Baseline, 6th week and 3rd month

Collaborators and Investigators

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

Sponsor

Kırıkkale University

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 (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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