NCT06326073

Brief Summary

It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

March 16, 2024

Last Update Submit

March 16, 2024

Conditions

PeriodontitisSmoking

Keywords

non surgical periodontal therapysmokingperiostinIL-17gingival crevicular fluid

Outcome Measures

Primary Outcomes (3)

  • Evaluation of Periostin levels

    The effect of non-surgical periodontal treatment in gingival crevicular fluid periostin levels

    0-15-30 days

  • Evaluation of IL-17A levels

    The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17A levels

    0-15-30 days

  • Evaluation of IL-17E levels

    The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17E levels

    0-15-30 days

Secondary Outcomes (1)

  • Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels

    0-15-30 days

Study Arms (4)

Group I: SP

EXPERIMENTAL

smokers with periodontitis

Procedure: Non Surgical Periodontal Treatment

Group II: P

EXPERIMENTAL

non-smokers with periodontitis

Procedure: Non Surgical Periodontal Treatment

Group III: SH

NO INTERVENTION

smokers with periodontal healthy individuals

Group IV: H

NO INTERVENTION

non-smokers with periodontal healthy individuals

Interventions

Non Surgical Periodontal TreatmentPROCEDURE

Phase 1 periodontal (full mouth debridement) treatment was applied to groups with periodontitis in one session.

Group I: SPGroup II: P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • generalized stage 3 periodontitis or periodontally healthy;
  • smoker ((≥10 cigarettes/day for \>5 years) or nonsmoker (never smoked in their lifetime);
  • not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause.

You may not qualify if:

  • Under 18 years of age
  • Those with a systemic disease
  • Cancer patients, those with a history of chemotherapy and radiotherapy
  • Pregnant and breastfeeding women
  • Those who smoke less than 10 cigarettes a day and those who quit smoking
  • Having received orthodontic treatment in the last 6 months
  • Using antibiotics, anti-inflammatory or any medication in the last 6 months
  • Those who do not consent voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Muge Luftioglu

    Ondokuz Mayıs Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

July 1, 2019

Primary Completion

February 1, 2021

Study Completion

July 1, 2021

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)