NCT06145685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

November 12, 2023

Last Update Submit

November 22, 2023

Conditions

Periodontal DiseasesSmoking Cessation

Keywords

Smoking CessationPeriodontal DiseasesInflammatory MarkersInterleukin-1betaProstaglandin E2Non-surgical therapySmoking

Outcome Measures

Primary Outcomes (2)

  • Levels of Prostaglandin E2

    Salivary biochemical analysis

    Baseline and 2 months

  • Interleukin 1 beta (in PG/ml)

    Salivary biochemical analysis

    Baseline and 2 months

Secondary Outcomes (5)

  • Pocket depth (in mm)

    Baseline and 9 months

  • clinical attachment level (in mm)

    Baseline and 9 months

  • bone gain (in mm)

    Baseline and 9 months

  • Plaque index (scores)

    Baseline and 9 months

  • Periodontal clinical parameters

    Baseline and 9 months

Study Arms (4)

Previous smokers - Minimally invasive

ACTIVE COMPARATOR

Minimally invasive non-surgical periodontal treatment

Procedure: Minimally invasive non-surgical periodontal therapy

Previous smokers - Conventional

ACTIVE COMPARATOR

Conventional non-surgical periodontal treatment

Procedure: Conventional non-surgical periodontal therapy

Smoker

ACTIVE COMPARATOR

Conventional non-surgical periodontal treatment

Procedure: Conventional non-surgical periodontal therapy

Non-smoker

ACTIVE COMPARATOR

Conventional non-surgical periodontal treatment

Procedure: Conventional non-surgical periodontal therapy

Interventions

Minimally invasive non-surgical periodontal therapyPROCEDURE

Minimally invasive non-surgical periodontal therapy

Previous smokers - Minimally invasive
Conventional non-surgical periodontal therapyPROCEDURE

Conventional non-surgical periodontal therapy

Non-smokerPrevious smokers - ConventionalSmoker

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Periodontal DiseasesSmoking CessationSmoking

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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 Record Dates

First Submitted

November 12, 2023

First Posted

November 24, 2023

Study Start

January 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

EG(1)