Back to resultsPeriostin and Non-Surgical Periodontal Treatment
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-Surgical Periodontal Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Chronic periodontitis, Gingival crevicular fluid, Gingivitis, Non-surgical periodontal treatment, Periostin
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Patients with chronic periodontitis
Patients with gingivitis
Participants with periodontal healthy
Arm Description
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.
Participants with G (n=30) had gingival index ≥ 2 and other inflammation signs.
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%.
Outcomes
Primary Outcome Measures
Change in periostin
Total amount of Periostin (pg/30 sec) in gingival crevicular fluid
Secondary Outcome Measures
Change in periodontal clinical parameter
Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04332965
Brief Title
Periostin and Non-Surgical Periodontal Treatment
Official Title
The Effect of Non-Surgical Periodontal Treatment on Gingival Crevicular Fluid Periostin Levels in Patients With Gingivitis and Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırıkkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Chronic periodontitis, Gingival crevicular fluid, Gingivitis, Non-surgical periodontal treatment, Periostin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic periodontitis
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with gingivitis
Arm Type
Experimental
Arm Description
Participants with G (n=30) had gingival index ≥ 2 and other inflammation signs.
Arm Title
Participants with periodontal healthy
Arm Type
No Intervention
Arm Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Non-Surgical Periodontal Treatment
Other Intervention Name(s)
Initial periodontal therapy
Intervention Description
Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
Primary Outcome Measure Information:
Title
Change in periostin
Description
Total amount of Periostin (pg/30 sec) in gingival crevicular fluid
Time Frame
Baseline, 6th week and 3rd month
Secondary Outcome Measure Information:
Title
Change in periodontal clinical parameter
Description
Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
Time Frame
Baseline, 6th week and 3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Periostin and Non-Surgical Periodontal Treatment
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