Chronic PeriodontitisPhase 1NCT02875470
Burs Versus Curettes in Root Planing.
A Phase 1 study testing Intensiv Perio Set and Gracey curette in people with Chronic Periodontitis, run by Ege University.
Trial summary
This study compares the efficacy of diamond burs and Gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. Read more about this study
- Who is it for?
- Ages 37 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Intensiv Perio Set and Gracey curette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Apr 2015
- Phase
- Phase 1
- 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 37 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- clinical diagnosis of generalized chronic periodontitis (Armitage 1999)
- presence of at least 3 teeth (1 molar, 2 non-molar teeth) with probing depth ≥ 5 mm in each quadrant
Who cannot join
- presence of any known systemic disease or using medications that affect periodontal tissues
- antibiotic treatment and/or periodontal treatment within the past 6 months
- tobacco usage during the last 12 months
- being pregnant or in the lactation period
About this study
Official title: Diamond Burs Versus Gracey Curettes and Efficacy of Root Planing in Chronic Periodontitis Patients
This study compares the efficacy of diamond burs and Gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. Two quadrants of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were treated with Gracey curettes. Also 21 hopeless teeth received root planing either with diamond burs or curettes or no treatment at all and were then extracted for microscopic evaluations.
Read the detailed description
Gracey curettes are the most widely used instruments for root planing and regarded as the gold standard, but their usage is technic sensitive and time consuming for the clinician and efficacy reduces in deep pockets, root irregularities, and furcations. Alternative sonic, ultrasonic and rotary instruments have been investigated for potential benefits in improving mechanical access. Sonic and ultrasonic instruments are used for scaling, but they cannot provide smooth root surfaces.
Intensiv Perio Set is a rotating diamond bur system developed for odontoplasty, scaling and root planing. It is used only in right angle hand piece, at rotation speeds of 6000 rpm, with reduced pressure application. These burs have two different head types for morphologically different areas; flame or tapered, three different grains; 75, 40, or 15 μm, with either a short or long neck for each unit. Burs with 75 μm grain are used only in odontoplasty, whereas, 40 and 15 μm burs are used for scaling and root planing.
- Conditions
- Chronic Periodontitis
- Being tested
- Intensiv Perio Set, Gracey curette
- Keywords
- non-surgical periodontal debridement, root planing/instrumentation, cytokine(s), dental plaque, microscopy, electron, scanning
- Medical subject headings
- Chronic Periodontitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensiv Perio SetDevice
Diamond burs for root planing
Gracey curetteDevice
| Study group | Role | What they receive |
|---|---|---|
| Intensiv Perio Set | Experimental | Root planing with diamond burs Receives: Device: Intensiv Perio Set |
| Gracey curette | Active comparator | Root planing with Gracey curettes Receives: Device: Gracey curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical tissue healing
Measured: 6 month
Secondary outcomes (3)
Changing of the amount of pathogen microorganisms
Measured: 1 month
Changing of the gingival crevicular fluid biomarkers
Measured: 1 month
Root surface characteristic according to Scanning Electron Microscope
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Fatma Türktekin, Ege University
- Investigators
- Eralp Buduneli, Proffessor, Study director, Department of Periodontology, Faculty of Dentistry, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875470
- Sponsor's protocol ID
- FTurktekin
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual data for all outcome measures will be made available within 3 years of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diamond Burs Versus Gracey Curettes and Efficacy of Root Planing in Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02875470
- Acronym / sponsor ID
- FTurktekin
- Conditions
- Chronic Periodontitis
- Keywords
- non-surgical periodontal debridement, root planing/instrumentation, cytokine(s), dental plaque, microscopy, electron, scanning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
This study compares the efficacy of diamond burs and Gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. Two quadrants of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were treated with Gracey curettes. Also 21 hopeless teeth received root planing either with diamond burs or curettes or no treatment at all and were then extracted for microscopic evaluations.
Detailed description
Gracey curettes are the most widely used instruments for root planing and regarded as the gold standard, but their usage is technic sensitive and time consuming for the clinician and efficacy reduces in deep pockets, root irregularities, and furcations. Alternative sonic, ultrasonic and rotary instruments have been investigated for potential benefits in improving mechanical access. Sonic and ultrasonic instruments are used for scaling, but they cannot provide smooth root surfaces.
Intensiv Perio Set is a rotating diamond bur system developed for odontoplasty, scaling and root planing. It is used only in right angle hand piece, at rotation speeds of 6000 rpm, with reduced pressure application. These burs have two different head types for morphologically different areas; flame or tapered, three different grains; 75, 40, or 15 μm, with either a short or long neck for each unit. Burs with 75 μm grain are used only in odontoplasty, whereas, 40 and 15 μm burs are used for scaling and root planing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensiv Perio Set | Experimental | Device: Intensiv Perio SetRoot planing with diamond burs |
| Gracey curette | Active comparator | Device: Gracey curetteRoot planing with Gracey curettes |
Who may qualify
- Ages
- 37 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of generalized chronic periodontitis (Armitage 1999)
- presence of at least 3 teeth (1 molar, 2 non-molar teeth) with probing depth ≥ 5 mm in each quadrant
Key exclusion criteria (4 listed)
- presence of any known systemic disease or using medications that affect periodontal tissues
- antibiotic treatment and/or periodontal treatment within the past 6 months
- tobacco usage during the last 12 months
- being pregnant or in the lactation period
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 |
|---|---|---|
| Intensiv Perio SetDiamond burs for root planing | Device | Intensiv Perio Set |
| Gracey curette | Device | Gracey curette |
Primary outcome
Clinical tissue healing
Time frame: 6 month
3 secondary outcomes
Changing of the amount of pathogen microorganisms
Time frame: 1 month
Changing of the gingival crevicular fluid biomarkers
Time frame: 1 month
Root surface characteristic according to Scanning Electron Microscope
Time frame: 6 month
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 23 Aug 2016.
- Individual participant dataSharing planned: Yes. De-identified individual data for all outcome measures will be made available within 3 years of study completion.
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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.
Eralp Buduneli, Proffessor study director
Department of Periodontology, Faculty of Dentistry, Ege University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intensiv Perio Set and Gracey curette in people with Chronic Periodontitis, 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 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 23 Aug 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical tissue healing (time frame: 6 month). 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 23 Aug 2016.