Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy

NCT ID: NCT06326073

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-07-01

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.

Detailed Description

The SH and H groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. However, after the GCF sampling, patients in the SP and P groups received Non-surgical periodontal treatment(NSPT) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session They were instructed to refrain from using any chemicals, including mouthwash, to remove plaque.

The periodontitis patients received a follow-up call on the 15th and 30th days following treatment. The GCF sampling procedure was first repeated on the teeth from which a previous GCF sample had been taken. Then, values for the clinical examination parameters (PI, GI, BOP, PD, and CAL) were once again measured and recorded. Daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. All these procedures were performed by a single investigator.

Conditions

Periodontitis; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group I: SP

smokers with periodontitis

Group Type: EXPERIMENTAL

Non Surgical Periodontal Treatment

Intervention Type: PROCEDURE

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

Group II: P

non-smokers with periodontitis

Group Type: EXPERIMENTAL

Non Surgical Periodontal Treatment

Intervention Type: PROCEDURE

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

Group III: SH

smokers with periodontal healthy individuals

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group IV: H

non-smokers with periodontal healthy individuals

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non Surgical Periodontal Treatment

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Sule Ozdogan

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muge Luftioglu

Role: STUDY_DIRECTOR

Ondokuz Mayıs Universitesi

Locations

Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OMUKAEK2019/324

Identifier Type: -

Identifier Source: org_study_id