Tooth StabilityPhase 2/3NCT01600118
Effect of Shock Waves on Dental Parameters
A Phase 2/3 study testing Extracorporeal shockwave therapy and No extracorporeal shockwave in people with Tooth Stability and Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Stability, Blood Flow
- What is being tested?
- Extracorporeal shockwave therapy and No extracorporeal shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy patients which don´t fulfill the exclusion criteria
Who cannot join
- diseases (syndroms, infections,...) which influence the bone turnover and blood flow
- medication, which influences the bone turnover and blood flow
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Bernhard Gottlieb University clinic of Dentistry
Vienna, State of Vienna, 1090
About this study
Official title: Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters
This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.
- Conditions
- Tooth Stability, Blood Flow
- Being tested
- Extracorporeal shockwave therapy, No extracorporeal shockwave
- Keywords
- tooth mobility, periodontal status, irregularity index, pulpal blood flow
- Medical subject headings
- Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyDevice
Also called Orthogold 100 MTS
1000 impulses
No extracorporeal shockwaveDevice
0 impulses, acoustic effect
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Active comparator | Extracorporeal shockwave therapy Receives: Device: Extracorporeal shockwave therapy |
| ESWT Placebo | Placebo comparator | No extracorporeal shockwave therapy Receives: Device: No extracorporeal shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontal stability of orthodontically aligned teeth
Measured: 6 months
Secondary outcomes (1)
pulpal blood flow
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth StabilityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Falkensammer, DMD,DMS, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600118
- Sponsor's protocol ID
- ESWT1
- Status last verified
- Oct 2015
- First submitted
- 14 May 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.
PubMed 18573992Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.
PubMed 12897619
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters
- ClinicalTrials.gov ID
- NCT01600118
- Acronym / sponsor ID
- ESWT1
- Conditions
- Tooth Stability, Blood Flow
- Keywords
- tooth mobility, periodontal status, irregularity index, pulpal blood flow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 May 2012 (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.
This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT | Active comparator | Device: Extracorporeal shockwave therapyExtracorporeal shockwave therapy |
| ESWT Placebo | Placebo comparator | Device: No extracorporeal shockwaveNo extracorporeal shockwave therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy patients which don´t fulfill the exclusion criteria
Key exclusion criteria (3 listed)
- diseases (syndroms, infections,...) which influence the bone turnover and blood flow
- medication, which influences the bone turnover and blood flow
- pregnancy
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 |
|---|---|---|
| Extracorporeal shockwave therapyAlso: Orthogold 100 MTS1000 impulses | Device | ESWT |
| No extracorporeal shockwave0 impulses, acoustic effect | Device | ESWT Placebo |
Primary outcome
periodontal stability of orthodontically aligned teeth
Time frame: 6 months
1 secondary outcome
pulpal blood flow
Time frame: 6 months
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 12 Oct 2015.
- Results publication: PubMed 18573992Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.
- Results publication: PubMed 12897619Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.
Related trials for Tooth Stability
Not yet recruiting
Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer
Tooth Stability, Periodontal Health
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 Phase 2/3 study testing Extracorporeal shockwave therapy and No extracorporeal shockwave in people with Tooth Stability and Blood Flow, run by Medical University of Vienna at 1 site in Austria.
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 3 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 12 Oct 2015. 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
periodontal stability of orthodontically aligned teeth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600118, which also lists 2 linked publications.
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 12 Oct 2015; AzTrials last refreshed its copy on 2 Nov 2026.