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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02875470
Other study ID # FTurktekin
Secondary ID
Status Completed
Phase Phase 1
First received August 9, 2016
Last updated August 17, 2016
Start date October 2013
Est. completion date April 2015

Study information

Verified date August 2016
Source Ege University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2015
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 37 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Intensiv Perio Set
Diamond burs for root planing
Gracey curette


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ege University University of Glasgow

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical tissue healing 6 month No
Secondary Changing of the amount of pathogen microorganisms 1 month No
Secondary Changing of the gingival crevicular fluid biomarkers 1 month No
Secondary Root surface characteristic according to Scanning Electron Microscope 6 month No
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