Periodontal DiseasesNCT06145685
Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy
A study testing Minimally invasive non-surgical periodontal therapy and Conventional non-surgical periodontal therapy in people with Periodontal Diseases and Smoking Cessation, run by October 6 University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Smoking Cessation
- What is being tested?
- Minimally invasive non-surgical periodontal therapy and Conventional non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Periodontal Diseases, Smoking Cessation
- Being tested
- Minimally invasive non-surgical periodontal therapy, Conventional non-surgical periodontal therapy
- Keywords
- Smoking Cessation, Periodontal Diseases, Inflammatory Markers, Interleukin-1beta, Prostaglandin E2, Non-surgical therapy, Smoking
- Medical subject headings
- Periodontal Diseases, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive non-surgical periodontal therapyProcedure or surgery
Minimally invasive non-surgical periodontal therapy
Conventional non-surgical periodontal therapyProcedure or surgery
Conventional non-surgical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Previous smokers - Minimally invasive | Active comparator | Minimally invasive non-surgical periodontal treatment Receives: Procedure: Minimally invasive non-surgical periodontal therapy |
| Previous smokers - Conventional | Active comparator | Conventional non-surgical periodontal treatment Receives: Procedure: Conventional non-surgical periodontal therapy |
| Smoker | Active comparator | Conventional non-surgical periodontal treatment Receives: Procedure: Conventional non-surgical periodontal therapy |
| Non-smoker | Active comparator | Conventional non-surgical periodontal treatment Receives: Procedure: Conventional non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Prostaglandin E2
Salivary biochemical analysis
Measured: Baseline and 2 months
Interleukin 1 beta (in PG/ml)
Salivary biochemical analysis
Measured: Baseline and 2 months
Secondary outcomes (5)
Pocket depth (in mm)
Periodontal clinical parameter
Measured: Baseline and 9 months
clinical attachment level (in mm)
Periodontal clinical parameter
Measured: Baseline and 9 months
bone gain (in mm)
Periodontal clinical parameter
Measured: Baseline and 9 months
Plaque index (scores)
Periodontal clinical parameters
Measured: Baseline and 9 months
Periodontal clinical parameters
Gingival index (scores)
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jan 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University, Misr University for Science and Technology
- Responsible party
- Principal investigator, Ahmed Y Gamal, Ain Shams University
- Investigators
- 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 EdinburghFatma 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 UniversityHussien Elkholy, Associate Professor, Study director, Associate Professor of Psychiatry - Faculty of Medicine - Ain Shams UniversityAhmed 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145685
- Sponsor's protocol ID
- 12-2014 OMD
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Cessation on Salivary IL-1β and PGE-2 Levels Following Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06145685
- Acronym / sponsor ID
- 12-2014 OMD
- Conditions
- Periodontal Diseases, Smoking Cessation
- Keywords
- Smoking Cessation, Periodontal Diseases, Inflammatory Markers, Interleukin-1beta, Prostaglandin E2, Non-surgical therapy, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University, Misr University for Science and Technology
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Previous smokers - Minimally invasive | Active comparator | Procedure: Minimally invasive non-surgical periodontal therapyMinimally invasive non-surgical periodontal treatment |
| Previous smokers - Conventional | Active comparator | Procedure: Conventional non-surgical periodontal therapyConventional non-surgical periodontal treatment |
| Smoker | Active comparator | Procedure: Conventional non-surgical periodontal therapyConventional non-surgical periodontal treatment |
| Non-smoker | Active comparator | Procedure: Conventional non-surgical periodontal therapyConventional non-surgical periodontal treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive non-surgical periodontal therapyMinimally invasive non-surgical periodontal therapy | Procedure or surgery | Previous smokers - Minimally invasive |
| Conventional non-surgical periodontal therapyConventional non-surgical periodontal therapy | Procedure or surgery | Non-smoker, Previous smokers - Conventional, Smoker |
Primary outcome
Levels of Prostaglandin E2
Time frame: Baseline and 2 months
Salivary biochemical analysis
Interleukin 1 beta (in PG/ml)
Time frame: Baseline and 2 months
Salivary biochemical analysis
5 secondary outcomes
Pocket depth (in mm)
Time frame: Baseline and 9 months
clinical attachment level (in mm)
Time frame: Baseline and 9 months
bone gain (in mm)
Time frame: Baseline and 9 months
Plaque index (scores)
Time frame: Baseline and 9 months
Periodontal clinical parameters
Time frame: Baseline and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive non-surgical periodontal therapy and Conventional non-surgical periodontal therapy in people with Periodontal Diseases and Smoking Cessation, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Prostaglandin E2 (time frame: Baseline and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.