Clinical trial NCT06145685: Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy
Official title: Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Smoking Cessation
Keywords: Smoking Cessation
Periodontal Diseases
Inflammatory Markers
Interleukin-1beta
Prostaglandin E2
Non-surgical therapy
Smoking
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
name: Misr University for Science and Technology
First posted: 2023-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Levels of Prostaglandin E2
timeFrame: Baseline and 2 months
measure: Interleukin 1 beta (in PG/ml)
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Pocket depth (in mm)
timeFrame: Baseline and 9 months
measure: clinical attachment level (in mm)
timeFrame: Baseline and 9 months
measure: bone gain (in mm)
timeFrame: Baseline and 9 months
measure: Plaque index (scores)
timeFrame: Baseline and 9 months
measure: Periodontal clinical parameters
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Master Degree in Diagnosis, Oral Medicine and Periodontology - Faculty of Dentistry - Ain Shams University, Membership of the Faculty of Dental Surgery of The Royal College of Surgeons of Edinburgh
name: Noura M ElShiaty, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Periodontology, Oral Medicine and Diagnosis - Faculty of Dentistry - Ain Shams University, Associate Professor of Oral Medicine and Periodontology - Faculty of Oral and Dental Medicine - Misr International University
name: Fatma H El-Demerdash, Associate Professor
role: STUDY_DIRECTOR
affiliation: Associate Professor of Psychiatry - Faculty of Medicine - Ain Shams University
name: Hussien Elkholy, Associate Professor
role: STUDY_DIRECTOR
affiliation: Professor of Oral Medicine, Periodontology and Oral Diagnosis - Faculty of Dentistry - Ain Shams University, Professor of Periodontology - College of Oral and Dental Surgery - Misr University for Science and Technology
name: Ahmed Y Gamal, Professor
role: STUDY_DIRECTOR
References: