- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875470
Burs Versus Curettes in Root Planing.
Diamond Burs Versus Gracey Curettes and Efficacy of Root Planing in Chronic Periodontitis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensiv Perio Set
Root planing with diamond burs
|
Diamond burs for root planing
|
|
Active Comparator: Gracey curette
Root planing with Gracey curettes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical tissue healing
Time Frame: 6 month
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changing of the amount of pathogen microorganisms
Time Frame: 1 month
|
1 month
|
|
Changing of the gingival crevicular fluid biomarkers
Time Frame: 1 month
|
1 month
|
|
Root surface characteristic according to Scanning Electron Microscope
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Eralp Buduneli, Proffessor, Department of Periodontology, Faculty of Dentistry, Ege University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FTurktekin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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