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CompletedNCT06145685Updated Nov 24, 2023

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

An interventional study of Minimally invasive non-surgical periodontal therapy and Conventional non-surgical periodontal therapy in Periodontal Diseases and Smoking Cessation, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2021, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases
  • Smoking Cessation

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Keywords

  • Smoking Cessation
  • Periodontal Diseases
  • Inflammatory Markers
  • Interleukin-1beta
  • Prostaglandin E2
  • Non-surgical therapy
  • Smoking
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Previous smokers - Minimally invasive

    Minimally invasive non-surgical periodontal treatment

    Procedure: Minimally invasive non-surgical periodontal therapy

  • Active comparator
    Previous smokers - Conventional

    Conventional non-surgical periodontal treatment

    Procedure: Conventional non-surgical periodontal therapy

  • Active comparator
    Smoker

    Conventional non-surgical periodontal treatment

    Procedure: Conventional non-surgical periodontal therapy

  • Active comparator
    Non-smoker

    Conventional non-surgical periodontal treatment

    Procedure: Conventional non-surgical periodontal therapy

Interventions

  • ProcedureMinimally invasive non-surgical periodontal therapy

    Minimally invasive non-surgical periodontal therapy

  • ProcedureConventional non-surgical periodontal therapy

    Conventional non-surgical periodontal therapy

06

What researchers measure

Primary outcomes

  1. Levels of Prostaglandin E2

    Salivary biochemical analysis

    Time frame: Baseline and 2 months

  2. Interleukin 1 beta (in PG/ml)

    Salivary biochemical analysis

    Time frame: Baseline and 2 months

Secondary outcomes

  1. Pocket depth (in mm)

    Periodontal clinical parameter

    Time frame: Baseline and 9 months

  2. clinical attachment level (in mm)

    Periodontal clinical parameter

    Time frame: Baseline and 9 months

  3. bone gain (in mm)

    Periodontal clinical parameter

    Time frame: Baseline and 9 months

  4. Plaque index (scores)

    Periodontal clinical parameters

    Time frame: Baseline and 9 months

  5. Periodontal clinical parameters

    Gingival index (scores)

    Time frame: Baseline and 9 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, 11566, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06145685
Lead sponsor
October 6 University
Collaborators
Ain Shams University, Misr University for Science and Technology
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) — Principal investigator
First posted
Nov 24, 2023
Start date
Jan 1, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Nov 24, 2023

Study contacts

Noura M ElShiaty, Dr.
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
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
study director · Associate Professor of Psychiatry - Faculty of Medicine - Ain Shams University
Ahmed Y Gamal, Professor
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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