NCT04430764

Brief Summary

This study aimed to investigate the effect of smoking and non-surgical periodontal treatment on gingival crevicular fluid CyPA and EMMPRIN levels in patients with periodontitis. Twenty-eight patients with periodontitis (14 non-smoker and 14 smoker) and 30 control subjects (15 non-smoker and 15 smoker) were included into the study. Non-surgical periodontal treatment was applied to all periodontitis patients. Periodontal parameters and GCF CyPA and EMMPRIN levels were evaluated during 3 months following non-surgical periodontal treatment. GCF CyPA and EMMPRIN levels were analyzed by ELISA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

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

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 9, 2020

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in gingival crevicular fluid CypA total amounts

    GCF CyPA levels were analyzed by ELISA

    Baseline, 1 week, 1., 3. months

  • Change in gingival crevicular fluid EMMPRIN total amounts

    GCF EMMPRIN levels were analyzed by ELISA

    Baseline, 1 week, 1., 3. months

Secondary Outcomes (2)

  • Change in probing depth

    Baseline, 1., 3. months

  • Change in bleeding on probing

    Baseline, 1., 3. months

Study Arms (2)

smoker

EXPERIMENTAL
Procedure: non-surgical periodontal treatment

non-smoker

ACTIVE COMPARATOR
Procedure: non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.

non-smokersmoker

Eligibility Criteria

Age29 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • generalized periodontitis with stage III-IV \& Grade B
  • no systemic and periodontal diseases
  • smokers (minimum 10 cigarettes per day for at least ten years)
  • non-smokers (never smoked)

You may not qualify if:

  • Systemic diseases
  • Infectious diseases
  • Pregnancy or lactating
  • Having periodontal treatment during the last 6 months
  • Having antibiotic treatment within the past 3 months
  • Former smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SmokingPeriodontitis

Condition Hierarchy (Ancestors)

BehaviorPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

June 12, 2020

Record last verified: 2020-06