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

Not Applicable

Completed

• Conditions: Periodontitis; Smoking
• Interventions: Procedure: Non Surgical Periodontal Treatment

• Registration Number: NCT06326073
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-07-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II: P	Non Surgical Periodontal Treatment	non-smokers with periodontitis
Group I: SP	Non Surgical Periodontal Treatment	smokers with periodontitis

Primary Outcome Measures

Name	Time	Method
Evaluation of IL-17E levels	0-15-30 days	The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17E levels
Evaluation of IL-17A levels	0-15-30 days	The effect of non-surgical periodontal treatment in gingival crevicular fluid IL-17A levels
Evaluation of Periostin levels	0-15-30 days	The effect of non-surgical periodontal treatment in gingival crevicular fluid periostin levels

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology; 🇹🇷 Samsun, Turkey