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

Sponsor

October 6 University (Other)

Overall Status

Completed

CT.gov ID

NCT06145685

Collaborator

Ain Shams University (Other), Misr University for Science and Technology (Other)

Enrollment

Location

Arms

13.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Smoking Cessation	Procedure: Minimally invasive non-surgical periodontal therapy Procedure: Conventional non-surgical periodontal therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Previous smokers - Minimally invasive Minimally invasive non-surgical periodontal treatment	Procedure: Minimally invasive non-surgical periodontal therapy Minimally invasive non-surgical periodontal therapy
Active Comparator: Previous smokers - Conventional Conventional non-surgical periodontal treatment	Procedure: Conventional non-surgical periodontal therapy Conventional non-surgical periodontal therapy
Active Comparator: Smoker Conventional non-surgical periodontal treatment	Procedure: Conventional non-surgical periodontal therapy Conventional non-surgical periodontal therapy
Active Comparator: Non-smoker Conventional non-surgical periodontal treatment	Procedure: Conventional non-surgical periodontal therapy Conventional non-surgical periodontal therapy

Outcome Measures

Primary Outcome Measures

Levels of Prostaglandin E2 [Baseline and 2 months]
Salivary biochemical analysis
Interleukin 1 beta (in PG/ml) [Baseline and 2 months]
Salivary biochemical analysis

Secondary Outcome Measures

Pocket depth (in mm) [Baseline and 9 months]
Periodontal clinical parameter
clinical attachment level (in mm) [Baseline and 9 months]
Periodontal clinical parameter
bone gain (in mm) [Baseline and 9 months]
Periodontal clinical parameter
Plaque index (scores) [Baseline and 9 months]
Periodontal clinical parameters
Periodontal clinical parameters [Baseline and 9 months]
Gingival index (scores)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	11566

Sponsors and Collaborators

October 6 University
Ain Shams University
Misr University for Science and Technology

Investigators

Principal Investigator: Noura M ElShiaty, Dr., 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
Study Director: Fatma H El-Demerdash, Associate Professor, 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
Study Director: Hussien Elkholy, Associate Professor, Associate Professor of Psychiatry - Faculty of Medicine - Ain Shams University
Study Director: Ahmed Y Gamal, Professor, 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Y Gamal, 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., Ain Shams University

ClinicalTrials.gov Identifier:

NCT06145685

Other Study ID Numbers:

12-2014 OMD

First Posted:

Nov 24, 2023

Last Update Posted:

Nov 24, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Y Gamal, 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., Ain Shams University

Additional relevant MeSH terms:

Periodontal Diseases

Study Results

No Results Posted as of Nov 24, 2023