NCT03915730

Brief Summary

A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40 periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80 subjects, were included in this study. Baseline GCF samples were obtained from all subjects and clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had received initial periodontal therapy, GCF samples were obtained and all clinical periodontal measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by enzyme-linked immunosorbent assay.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

April 11, 2019

Last Update Submit

April 14, 2019

Conditions

Keywords

Chronic periodontitisgingival crevicular fluidinitial periodontal therapypeptidoglycan recognition proteinssmoking

Outcome Measures

Primary Outcomes (1)

  • Change in peptidoglycan recognition protein-1

    Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid

    Baseline and 3 months

Secondary Outcomes (1)

  • Change in periodontal clinical parameter

    Baseline and 3 months

Study Arms (4)

Smokers with chronic periodontitis

EXPERIMENTAL

Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.

Other: Initial periodontal therapy

Non-smokers with chronic periodontitis

EXPERIMENTAL

Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Never smoked patients were included into the nonsmoker group

Other: Initial periodontal therapy

Smokers with periodontal healthy

NO INTERVENTION

Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of \<10% and a probing depth of ≤3 mm Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.

Non-smokers with periodontal healthy

NO INTERVENTION

Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of \<10% and a probing depth of ≤3 mm Never smoked patients were included into the nonsmoker group

Interventions

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

Non-smokers with chronic periodontitisSmokers with chronic periodontitis

Eligibility Criteria

Age22 Years - 56 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of severe chronic periodontitis
  • 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

Cigarette SmokingChronic PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Tobacco SmokingBehaviorTobacco UsePeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Assistant Professor

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

November 1, 2017

Last Updated

April 16, 2019

Record last verified: 2019-04