NCT01945632

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

July 2, 2013

Last Update Submit

September 17, 2013

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Surface roughness

    two years

Study Arms (4)

no treatment

NO INTERVENTION

Control group with no treatment.

root planing (gracey curettes)

EXPERIMENTAL

treatment with root planing using conventional gracey curettes

Device: conventional gracey curettes

Vertically oscillating ultrasonic device

EXPERIMENTAL

Treatment done with vertically oscillating ultrasonic device

Device: Vertically oscillating ultrasonic device

Device: piezoelectric ultrasonic scraper

EXPERIMENTAL

Treatment using a piezoelectric ultrasonic scraper

Device: piezoelectric ultrasonic scraper

Interventions

conventional gracey curettesDEVICE
root planing (gracey curettes)
Vertically oscillating ultrasonic deviceDEVICE
Vertically oscillating ultrasonic device
piezoelectric ultrasonic scraperDEVICE
Device: piezoelectric ultrasonic scraper

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing programmed tooth extraction for chronic advanced periodontitis.

You may not qualify if:

  • Patients with no advanced periodontitis or patients that refused the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Granada

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD.

Study Record Dates

First Submitted

July 2, 2013

First Posted

September 18, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

ES(1)