Smoking, CigaretteNCT03915730

Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy

A study testing Initial periodontal therapy in people with Smoking, Cigarette, run by Kırıkkale University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 56 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Cigarette
What is being tested?: Initial periodontal therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Aug 2016to Nov 2017
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 22 to 56 years
Healthy volunteers accepted
Adult

Who may be able to join

Clinical diagnosis of severe chronic periodontitis
Clinical diagnosis of periodontal health

Who cannot join

have any systemic disease,
to be alcohol consumer,
to receive any periodontal therapy in the past 6 months,
to take any drugs regularly
to be pregnant and/or lactate.

About this study

Official title: The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis

A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40 periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80 subjects, were included in this study. Baseline GCF samples were obtained from all subjects and clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had received initial periodontal therapy, GCF samples were obtained and all clinical periodontal measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by enzyme-linked immunosorbent assay.

Read the detailed description

Peptidoglycan recognition proteins (PGRPs) are one of the antimicrobial peptides that play a role in innate immunity and act against the bacterial cell wall. Smoking is the most important environmental risk factor for periodontitis. This study determined the effect of smoking on PGRP-1 levels in gingival crevicular fluid (GCF) in smokers and nonsmokers with chronic periodontitis (CP) following initial periodontal therapy.

Conditions: Smoking, Cigarette
Being tested: Initial periodontal therapy
Keywords: Chronic periodontitis, gingival crevicular fluid, initial periodontal therapy, peptidoglycan recognition proteins, smoking
Medical subject headings: Cigarette Smoking, Chronic Periodontitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Initial periodontal therapyOther
Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.

Study groups in NCT03915730
Study group	Role	What they receive
Smokers with chronic periodontitis	Experimental	Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers. Receives: Other: Initial periodontal therapy
Non-smokers with chronic periodontitis	Experimental	Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Never smoked patients were included into the nonsmoker group Receives: Other: Initial periodontal therapy
Smokers with periodontal healthy	No intervention	Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.
Non-smokers with periodontal healthy	No intervention	Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Never smoked patients were included into the nonsmoker group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in peptidoglycan recognition protein-1
Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid
Measured: Baseline and 3 months

Secondary outcomes (1)

Change in periodontal clinical parameter
Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Nov 2017

First posted16 Apr 2019
Study startAug 2016
Primary completionJul 2017
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Smoking, CigaretteStudies 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: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915730
Sponsor's protocol ID: 2016/026
Status last verified: Apr 2019
First submitted: 11 Apr 2019
Last updated: 16 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis
ClinicalTrials.gov ID: NCT03915730
Acronym / sponsor ID: 2016/026
Conditions: Smoking, Cigarette
Keywords: Chronic periodontitis, gingival crevicular fluid, initial periodontal therapy, peptidoglycan recognition proteins, smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Kırıkkale UniversityUniversity, hospital or other
Study start: Aug 2016 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 16 Apr 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Smokers with chronic periodontitis	Experimental	Other: Initial periodontal therapyPatients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.
Non-smokers with chronic periodontitis	Experimental	Other: Initial periodontal therapyPatients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Never smoked patients were included into the nonsmoker group
Smokers with periodontal healthy	No intervention	–Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.
Non-smokers with periodontal healthy	No intervention	–Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Never smoked patients were included into the nonsmoker group

Who may qualify

Ages: 22 to 56 years
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Clinical diagnosis of severe chronic periodontitis
Clinical diagnosis of periodontal health

Key exclusion criteria (5 listed)

have any systemic disease,
to be alcohol consumer,
to receive any periodontal therapy in the past 6 months,
to take any drugs regularly
to be pregnant and/or lactate.

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
Initial periodontal therapyScaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.	Other	Non-smokers with chronic periodontitis, Smokers with chronic periodontitis

Primary outcome

Change in peptidoglycan recognition protein-1
Time frame: Baseline and 3 months
Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid

1 secondary outcome

Change in periodontal clinical parameter
Time frame: Baseline and 3 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 16 Apr 2019.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Initial periodontal therapy in people with Smoking, Cigarette, run by Kırıkkale University.

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 5 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Change in peptidoglycan recognition protein-1 (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915730.

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 16 Apr 2019.