Generalized Aggressive PeriodontitisNCT03512938
Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
A study testing Non-surgical periodontal therapy in people with Generalized Aggressive Periodontitis and Smoking, run by Ege University.
Trial summary
Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Generalized Aggressive Periodontitis, Smoking
- What is being tested?
- Non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2014to 28 Sep 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease
- Having at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and six teeth other than first molars and incisors with similar PD and CAL measurements
- Familial aggregation
Who cannot join
- Medical disorders such as diabetes mellitus, immunological disorders
- Having an antibiotic or periodontal treatment in the last 6 months
- Having <15 teeth
About this study
Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. It is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. It was hypothesized that non-smoker patients with generalized aggressive periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.
- Conditions
- Generalized Aggressive Periodontitis, Smoking
- Being tested
- Non-surgical periodontal therapy
- Keywords
- Generalized aggressive periodontitis, Non-surgical periodontal therapy, Periodontopathogens, Smoking, Gingival crevicular fluid
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapyProcedure or surgery
Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoker Group | Active comparator | This group included non-smoker generalized aggressive periodontitis patients. Receives: Procedure: Non-surgical periodontal therapy |
| Smoker Group | Experimental | This group included smoker generalized aggressive periodontitis patients. Receives: Procedure: Non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Attachment Level (CAL)
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Secondary outcomes (7)
Change in Probing Depth (PD)
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Bleeding on Probing (BoP)
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Plaque Index (PI)
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the salivary biomarkers
In the morning following an overnight fast, during which subjects were requested not to drink (except water) or to chew gum, whole saliva samples were obtained by expectorating into polypropylene tubes; clinical periodontal measurements and any necessary periodontal interventions were then carried out. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the serum biomarkers
Nine milliliters of venous blood were taken from the antecubital vein by a standard venipuncture method and centrifuged for 10 minutes at 3,000 rpm, separating serum from the cells. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the gingival crevicular fluid (GCF) biomarkers
GCF samples were obtained from buccal aspects of one interproximal site in each quadrant. Supragingival plaque was removed carefully by sterile curettes; the surfaces were dried and isolated by cotton rolls. Filter paper strips were placed in the orifices of the gingival sulcus/pocket for 30 seconds. Care was used to avoid mechanical trauma, and strips contaminated with blood were discarded. The absorbed GCF volume was estimated by a calibrated instrument. The readings of GCF sample volumes were converted to an actual volume (μL) by reference to the standard curve. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the amount of pathogen microorganisms
Plaque samples were collected from the same sites by sterile paper points from the base of the pockets. Paper points were inserted into the deepest part of the pocket and kept for 5 seconds. Paper points were then placed into propylene tubes. Real-time polymerase chain reaction was used for detection and quantification of bacterial cell copy numbers in 1 mg plaque.
Measured: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start23 Jun 2014
- Primary completion8 Feb 2016
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Aggressive PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Nurcan Buduneli, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512938
- Sponsor's protocol ID
- 2014-DIS-013
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
- ClinicalTrials.gov ID
- NCT03512938
- Acronym / sponsor ID
- 2014-DIS-013
- Conditions
- Generalized Aggressive Periodontitis, Smoking
- Keywords
- Generalized aggressive periodontitis, Non-surgical periodontal therapy, Periodontopathogens, Smoking, Gingival crevicular fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 8 Feb 2016 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 1 May 2018 (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.
Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. It is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. It was hypothesized that non-smoker patients with generalized aggressive periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-smoker Group | Active comparator | Procedure: Non-surgical periodontal therapyThis group included non-smoker generalized aggressive periodontitis patients. |
| Smoker Group | Experimental | Procedure: Non-surgical periodontal therapyThis group included smoker generalized aggressive periodontitis patients. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease
- Having at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and six teeth other than first molars and incisors with similar PD and CAL measurements
- Familial aggregation
Key exclusion criteria (3 listed)
- Medical disorders such as diabetes mellitus, immunological disorders
- Having an antibiotic or periodontal treatment in the last 6 months
- Having <15 teeth
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 |
|---|---|---|
| Non-surgical periodontal therapyPatients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient. | Procedure or surgery | Non-smoker Group, Smoker Group |
Primary outcome
Change in Clinical Attachment Level (CAL)
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
7 secondary outcomes
Change in Probing Depth (PD)
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Bleeding on Probing (BoP)
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Plaque Index (PI)
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the salivary biomarkers
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the serum biomarkers
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the gingival crevicular fluid (GCF) biomarkers
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the amount of pathogen microorganisms
Time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
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 1 May 2018.
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 Non-surgical periodontal therapy in people with Generalized Aggressive Periodontitis and Smoking, run by Ege 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 3 inclusion and 3 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 1 May 2018. 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 Clinical Attachment Level (CAL) (time frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy). 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 1 May 2018.