NCT04332965

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 1, 2020

Last Update Submit

April 2, 2020

Conditions

Keywords

Chronic periodontitisGingival crevicular fluidGingivitisNon-surgical periodontal treatmentPeriostin

Outcome Measures

Primary Outcomes (1)

  • Change in periostin

    Total amount of Periostin (pg/30 sec) in gingival crevicular fluid

    Baseline, 6th week and 3rd month

Secondary Outcomes (1)

  • Change in periodontal clinical parameter

    Baseline, 6th week and 3rd month

Study Arms (3)

Patients with chronic periodontitis

EXPERIMENTAL

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

Patients with gingivitis

EXPERIMENTAL

Participants with G (n=30) had gingival index ≥ 2 and other inflammation signs.

Procedure: Non-Surgical Periodontal Treatment

Participants with periodontal healthy

NO INTERVENTION

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%.

Interventions

Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.

Also known as: Initial periodontal therapy
Patients with chronic periodontitisPatients with gingivitis

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesChronic PeriodontitisGingivitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsGingival Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

April 3, 2020

Record last verified: 2020-04