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Completed

NCT Number: NCT06145685

Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy

The aim of this study is to evaluate the effect of smoking cessation on inflammatory markers following non-surgical treatment of periodontal disease. This is to assess the period of smoking abstinence needed before any periodontal surgery in order to reverse the negative effects of the reported increased levels of inflammatory markers (IL-1β and PGE2 in this study) associated with smoking on the healing and the periodontium.

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Key information

Conditions

Periodontal Diseases Behavior Health Behavior Mouth Diseases Smoking Smoking Cessation Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11566, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with advanced chronic periodontitis upon clinical examination with clinical attachment loss (CAL) more than 5 mm.
  • Patients willing to quit smoking to be included in two groups, while patients unwilling to quit smoking to be included in the third group, and the non-smokers as the fourth group.

Exclusion criteria

  • Any systemic illness known to affect the outcome.
  • Systemic antimicrobial or anti-inflammatory drug therapy within the last 3 months prior to the study.
  • Patients unable to perform routine oral hygiene procedures.
  • Patients using other forms of tobacco.

Treatment and study plan

Minimally invasive non-surgical periodontal therapy

Procedure

Minimally invasive non-surgical periodontal therapy

Conventional non-surgical periodontal therapy

Procedure

Conventional non-surgical periodontal therapy

Primary outcomes

  1. Levels of Prostaglandin E2

    Time frame: Baseline and 2 months

    Salivary biochemical analysis

  2. Interleukin 1 beta (in PG/ml)

    Time frame: Baseline and 2 months

    Salivary biochemical analysis

Secondary outcomes

  1. Pocket depth (in mm)

    Time frame: Baseline and 9 months

    Periodontal clinical parameter

  2. clinical attachment level (in mm)

    Time frame: Baseline and 9 months

    Periodontal clinical parameter

  3. bone gain (in mm)

    Time frame: Baseline and 9 months

    Periodontal clinical parameter

  4. Plaque index (scores)

    Time frame: Baseline and 9 months

    Periodontal clinical parameters

  5. Periodontal clinical parameters

    Time frame: Baseline and 9 months

    Gingival index (scores)

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Ain Shams University
  • Misr University for Science and Technology

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

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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