Back to resultsEffect of Root Planing on Surface Topography.
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
conventional gracey curettes
Vertically oscillating ultrasonic device
piezoelectric ultrasonic scraper
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing programmed tooth extraction for chronic advanced periodontitis.
Exclusion Criteria:
- Patients with no advanced periodontitis or patients that refused the treatment.
Sites / Locations
- School of Dentistry, University of Granada
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
no treatment
root planing (gracey curettes)
Vertically oscillating ultrasonic device
Device: piezoelectric ultrasonic scraper
Arm Description
Control group with no treatment.
treatment with root planing using conventional gracey curettes
Treatment done with vertically oscillating ultrasonic device
Treatment using a piezoelectric ultrasonic scraper
Outcomes
Primary Outcome Measures
Surface roughness
Secondary Outcome Measures
Full Information
NCT ID
NCT01945632
First Posted
July 2, 2013
Last Updated
September 17, 2013
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT01945632
Brief Title
Effect of Root Planing on Surface Topography.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In a clinical trial of 19 patients, 44 single-rooted teeth will be randomly assigned to one of four groups for: 1) no treatment, 2) manual root planing with curettes; 3) root planing with piezoelectric ultrasonic scraper [PU]; or 4) root planing with vertically oscillating ultrasonic device [VOU]. Post-treatment, the teeth will be extracted and their topography analyzed in 124 observations with white light confocal microscopy, measuring the roughness parameters Rp, Rv, Rt, Ra, Rq, Rku, and Rsk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
Control group with no treatment.
Arm Title
root planing (gracey curettes)
Arm Type
Experimental
Arm Description
treatment with root planing using conventional gracey curettes
Arm Title
Vertically oscillating ultrasonic device
Arm Type
Experimental
Arm Description
Treatment done with vertically oscillating ultrasonic device
Arm Title
Device: piezoelectric ultrasonic scraper
Arm Type
Experimental
Arm Description
Treatment using a piezoelectric ultrasonic scraper
Intervention Type
Device
Intervention Name(s)
conventional gracey curettes
Intervention Type
Device
Intervention Name(s)
Vertically oscillating ultrasonic device
Intervention Type
Device
Intervention Name(s)
piezoelectric ultrasonic scraper
Primary Outcome Measure Information:
Title
Surface roughness
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing programmed tooth extraction for chronic advanced periodontitis.
Exclusion Criteria:
Patients with no advanced periodontitis or patients that refused the treatment.
Facility Information:
Facility Name
School of Dentistry, University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
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Effect of Root Planing on Surface Topography.
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