Chronic PeriodontitisNCT01945632
Effect of Root Planing on Surface Topography.
A study testing conventional gracey curettes, Vertically oscillating ultrasonic device and piezoelectric ultrasonic scraper in people with Chronic Periodontitis, run by Universidad de Granada at 1 site in Spain.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- conventional gracey curettes, Vertically oscillating ultrasonic device and piezoelectric ultrasonic scraper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing programmed tooth extraction for chronic advanced periodontitis.
Who cannot join
- Patients with no advanced periodontitis or patients that refused the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Periodontitis
- Being tested
- conventional gracey curettes, Vertically oscillating ultrasonic device, piezoelectric ultrasonic scraper
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional gracey curettesDevice
Vertically oscillating ultrasonic deviceDevice
piezoelectric ultrasonic scraperDevice
| Study group | Role | What they receive |
|---|---|---|
| no treatment | No intervention | Control group with no treatment. |
| root planing (gracey curettes) | Experimental | treatment with root planing using conventional gracey curettes Receives: Device: conventional gracey curettes |
| Vertically oscillating ultrasonic device | Experimental | Treatment done with vertically oscillating ultrasonic device Receives: Device: Vertically oscillating ultrasonic device |
| Device: piezoelectric ultrasonic scraper | Experimental | Treatment using a piezoelectric ultrasonic scraper Receives: Device: piezoelectric ultrasonic scraper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface roughness
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ignacio Rosales Leal, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945632
- Sponsor's protocol ID
- root planing tophography
- Status last verified
- Sep 2013
- First submitted
- 2 Jul 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Root Planing on Surface Topography.
- ClinicalTrials.gov ID
- NCT01945632
- Acronym / sponsor ID
- root planing tophography
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no treatment | No intervention | –Control group with no treatment. |
| root planing (gracey curettes) | Experimental | Device: conventional gracey curettestreatment with root planing using conventional gracey curettes |
| Vertically oscillating ultrasonic device | Experimental | Device: Vertically oscillating ultrasonic deviceTreatment done with vertically oscillating ultrasonic device |
| Device: piezoelectric ultrasonic scraper | Experimental | Device: piezoelectric ultrasonic scraperTreatment using a piezoelectric ultrasonic scraper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing programmed tooth extraction for chronic advanced periodontitis.
Key exclusion criteria (1 listed)
- Patients with no advanced periodontitis or patients that refused the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional gracey curettes | Device | root planing (gracey curettes) |
| Vertically oscillating ultrasonic device | Device | Vertically oscillating ultrasonic device |
| piezoelectric ultrasonic scraper | Device | Device: piezoelectric ultrasonic scraper |
Primary outcome
Surface roughness
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional gracey curettes, Vertically oscillating ultrasonic device and piezoelectric ultrasonic scraper in people with Chronic Periodontitis, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface roughness (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.