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Burs Versus Curettes in Root Planing.

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Intensiv Perio Set

Gracey curette

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring non-surgical periodontal debridement, root planing/instrumentation, cytokine(s), dental plaque, microscopy, electron, scanning

Eligibility Criteria

37 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensiv Perio Set

Gracey curette

Arm Description

Root planing with diamond burs

Root planing with Gracey curettes

Outcomes

Primary Outcome Measures

Clinical tissue healing

Secondary Outcome Measures

Changing of the amount of pathogen microorganisms

Changing of the gingival crevicular fluid biomarkers

Root surface characteristic according to Scanning Electron Microscope

Full Information

NCT ID

NCT02875470

First Posted

August 9, 2016

Last Updated

August 17, 2016

Sponsor

Ege University

Collaborators

University of Glasgow

1. Study Identification

Unique Protocol Identification Number

NCT02875470

Brief Title

Burs Versus Curettes in Root Planing.

Official Title

Diamond Burs Versus Gracey Curettes and Efficacy of Root Planing in Chronic Periodontitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

Collaborators

University of Glasgow

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

non-surgical periodontal debridement, root planing/instrumentation, cytokine(s), dental plaque, microscopy, electron, scanning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensiv Perio Set

Arm Type

Experimental

Arm Description

Root planing with diamond burs

Arm Title

Gracey curette

Arm Type

Active Comparator

Arm Description

Root planing with Gracey curettes

Intervention Type

Device

Intervention Name(s)

Intensiv Perio Set

Intervention Description

Diamond burs for root planing

Intervention Type

Device

Intervention Name(s)

Gracey curette

Primary Outcome Measure Information:

Title

Clinical tissue healing

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Changing of the amount of pathogen microorganisms

Time Frame

1 month

Title

Changing of the gingival crevicular fluid biomarkers

Time Frame

1 month

Title

Root surface characteristic according to Scanning Electron Microscope

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

37 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eralp Buduneli, Proffessor

Organizational Affiliation

Department of Periodontology, Faculty of Dentistry, Ege University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual data for all outcome measures will be made available within 3 years of study completion.

Learn more about this trial

Burs Versus Curettes in Root Planing.

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