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

NCT ID: NCT06145685

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Previous smokers - Minimally invasive

Minimally invasive non-surgical periodontal treatment

Group Type ACTIVE_COMPARATOR

Minimally invasive non-surgical periodontal therapy

Intervention Type PROCEDURE

Minimally invasive non-surgical periodontal therapy

Previous smokers - Conventional

Conventional non-surgical periodontal treatment

Group Type ACTIVE_COMPARATOR

Conventional non-surgical periodontal therapy

Intervention Type PROCEDURE

Conventional non-surgical periodontal therapy

Smoker

Conventional non-surgical periodontal treatment

Group Type ACTIVE_COMPARATOR

Conventional non-surgical periodontal therapy

Intervention Type PROCEDURE

Conventional non-surgical periodontal therapy

Non-smoker

Conventional non-surgical periodontal treatment

Group Type ACTIVE_COMPARATOR

Conventional non-surgical periodontal therapy

Intervention Type PROCEDURE

Conventional non-surgical periodontal therapy

Interventions

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Minimally invasive non-surgical periodontal therapy

Minimally invasive non-surgical periodontal therapy

Intervention Type PROCEDURE

Conventional non-surgical periodontal therapy

Conventional non-surgical periodontal therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Misr University for Science and Technology

OTHER

Sponsor Role collaborator

October 6 University

OTHER

Sponsor Role lead

Responsible Party

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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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noura M ElShiaty, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Fatma H El-Demerdash, Associate Professor

Role: STUDY_DIRECTOR

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

Hussien Elkholy, Associate Professor

Role: STUDY_DIRECTOR

Associate Professor of Psychiatry - Faculty of Medicine - Ain Shams University

Ahmed Y Gamal, Professor

Role: STUDY_DIRECTOR

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

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12-2014 OMD

Identifier Type: -

Identifier Source: org_study_id