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

Evaluation of the GCF Periostin, IL-17A and IL-17E Levels of Smoking and Non-smoking Periodontitis Patients Received Periodontal Treatment: Short-term Follow-up Study

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Periodontitis
• Intervention / Treatment: Procedure: Non Surgical Periodontal Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55270
    • Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: SP; smokers with periodontitis	Procedure: Non Surgical Periodontal Treatment; Phase 1 periodontal (full mouth debridement) treatment was applied to groups with periodontitis in one session.
Experimental: Group II: P; non-smokers with periodontitis	Procedure: Non Surgical Periodontal Treatment; Phase 1 periodontal (full mouth debridement) treatment was applied to groups with periodontitis in one session.
No Intervention: Group III: SH; smokers with periodontal healthy individuals
No Intervention: Group IV: H; non-smokers with periodontal healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels	Comparisons between groups were made to evaluate the effect of smoking on non-surgical periodontal treatment.	0-15-30 days

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Director: Muge Luftioglu, Ondokuz Mayıs Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: smoking; IL-17; gingival crevicular fluid; non surgical periodontal therapy; periostin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: OMUKAEK2019/324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No