Mesial Movement of TeethPhase 2/3NCT01695928
Effect of Shock Waves on Tooth Movement and Miniscrew Stability
A Phase 2/3 study testing Extracorporeal shockwave therapy in people with Mesial Movement of Teeth and Miniscrew Stability, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mesial Movement of Teeth, Miniscrew Stability
- What is being tested?
- Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2012to Jan 2014
- 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
- disease (syndroms,infections,...) which influence the bone turnover and the oral health
- medication, which influences the bone turnover and the oral health
- 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 Orthodontic Tooth Movement and Miniscrew Stability
The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically.
This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.
- Conditions
- Mesial Movement of Teeth, Miniscrew Stability
- Being tested
- Extracorporeal shockwave therapy, ESWT placebo
- Keywords
- Velocity, Location, Periodontal status
- Medical subject headings
- Mesial Movement of Teeth
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
ESWT placeboDevice
Also called Orthogold 100 MTS
0 impulses, acoustic effect
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shockwave therapy (ESWT) | Active comparator | Active treatment Receives: Device: Extracorporeal shockwave therapy |
| ESWT Placebo | Placebo comparator | No extracoporeal shockwave therapy Receives: Device: ESWT placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic tooth movement
Measured: 4 months
Secondary outcomes (1)
Miniscrew stability
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mesial Movement of TeethStudies 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
- 30 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
- Investigators
- Hans P Bantleon, Prof, M.D., Study chair, Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695928
- Sponsor's protocol ID
- ESWT2
- Status last verified
- Oct 2015
- First submitted
- 26 Sep 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 12897619Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.
PubMed 21939106Falkensammer F, Rausch-Fan X, Arnhart C, Krall C, Schaden W, Freudenthaler J. Impact of extracorporeal shock-wave therapy on the stability of temporary anchorage devices in adults: a single-center, randomized, placebo-controlled clinical trial. Am J Orthod Dentofacial Orthop. 2014 Oct;146(4):413-22. doi: 10.1016/j.ajodo.2014.06.008.
PubMed 25263143
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 Orthodontic Tooth Movement and Miniscrew Stability
- ClinicalTrials.gov ID
- NCT01695928
- Acronym / sponsor ID
- ESWT2
- Conditions
- Mesial Movement of Teeth, Miniscrew Stability
- Keywords
- Velocity, Location, Periodontal status
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Sep 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.
The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically.
This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shockwave therapy (ESWT) | Active comparator | Device: Extracorporeal shockwave therapyActive treatment |
| ESWT Placebo | Placebo comparator | Device: ESWT placeboNo extracoporeal 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)
- disease (syndroms,infections,...) which influence the bone turnover and the oral health
- medication, which influences the bone turnover and the oral health
- 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 | Extracorporeal shockwave therapy (ESWT) |
| ESWT placeboAlso: Orthogold 100 MTS0 impulses, acoustic effect | Device | ESWT Placebo |
Primary outcome
Orthodontic tooth movement
Time frame: 4 months
1 secondary outcome
Miniscrew stability
Time frame: 4 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.
- Results publication: PubMed 21939106Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.
- Derived from this study: PubMed 25263143Falkensammer F, Rausch-Fan X, Arnhart C, Krall C, Schaden W, Freudenthaler J. Impact of extracorporeal shock-wave therapy on the stability of temporary anchorage devices in adults: a single-center, randomized, placebo-controlled clinical trial. Am J Orthod Dentofacial Orthop. 2014 Oct;146(4):413-22. doi: 10.1016/j.ajodo.2014.06.008.
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.
Hans P Bantleon, Prof, M.D. study chair
Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics
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 in people with Mesial Movement of Teeth and Miniscrew Stability, 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?
Orthodontic tooth movement (time frame: 4 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 NCT01695928, which also lists 4 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 6 Nov 2026.