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Completed

NCT Number: NCT06326073

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non Surgical Periodontal Treatment

Procedure

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

Primary outcomes

  1. Evaluation of Periostin levels

    Time frame: 0-15-30 days

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

  2. Evaluation of IL-17A levels

    Time frame: 0-15-30 days

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

  3. Evaluation of IL-17E levels

    Time frame: 0-15-30 days

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

Secondary outcomes

  1. Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels

    Time frame: 0-15-30 days

    Comparisons between groups were made to evaluate the effect of smoking on non-surgical periodontal treatment.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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