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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06145685
• Other study ID #: 12-2014 OMD
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2023
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Smoking Cessation

Intervention

Procedure:
• Minimally invasive non-surgical periodontal therapy
Minimally invasive non-surgical periodontal therapy
• Conventional non-surgical periodontal therapy
Conventional non-surgical periodontal therapy

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
October 6 University	Ain Shams University, Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Prostaglandin E2	Salivary biochemical analysis	Baseline and 2 months
Primary	Interleukin 1 beta (in PG/ml)	Salivary biochemical analysis	Baseline and 2 months
Secondary	Pocket depth (in mm)	Periodontal clinical parameter	Baseline and 9 months
Secondary	clinical attachment level (in mm)	Periodontal clinical parameter	Baseline and 9 months
Secondary	bone gain (in mm)	Periodontal clinical parameter	Baseline and 9 months
Secondary	Plaque index (scores)	Periodontal clinical parameters	Baseline and 9 months
Secondary	Periodontal clinical parameters	Gingival index (scores)	Baseline and 9 months