Loss of Teeth Due to ExtractionShockwaveNCT04331028
Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
A study testing Shockwave therapy in people with Loss of Teeth Due to Extraction and Bone Resorption, run by Rui Figueiredo at 1 site in Spain.
Trial summary
The extracorporeal shock wave therapy (ESWT) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loss of Teeth Due to Extraction, Bone Resorption
- What is being tested?
- Shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Dec 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 - 65 years old.
- Non-smoking patients.
- Patients committed to rehabilitate the extraction socket with an implant.
- Lack of pathology in the surrounding area.
- Cooperative patients with serious commitment to follow the investigator's postoperative visits, who must sign the informed consent.
- Patients that need a conventional anterior maxillary single tooth extraction.
Who cannot join
- Systemic illnesses (ASA III or above) that could contraindicate a surgical intervention or modify the wound healing.
- Patients with cardiopathies.
- Patients taking hormones, calcium or oral or endovenous bisphosphonates.
- Patients with uncontrolled periodontitis / periimplantitis.
- Smokers.
- Patients with implant/s in the upper maxilla.
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- Surgical extractions that require rising a flap or ostectomy.
- Bone defects larger of 2 mms in alveolar sockets due to cortical bone defect or resorption, fenestrations or/and dehiscences.
- Guided bone regeneration need.
- Periapical radiolucency larger than 2-3 mms.
Trial locations and contacts
1 site in 1 country.
About this study
The extracorporeal shock wave therapy (ESWT) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies.
The investigators main hypothesis is that the application of extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth should prevent further residual alveolar bone resorption and will enhance vital bone formation.
Read more
The investigators null hypothesis is that applying extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth has no influence in the alveolar bone remodeling process.
Therefore, the investigators main objective is to evaluate the efficacy of the ESWT in the prevention of alveolar bone resorption after an extraction with a volumetric exam through computer tomographies (CT) analysis. The investigators secondary objective is to determine the effect of ESWT in the internal bone healing process of these postextraction alveolar sockets, measuring the bone density in the CT (Hounsfield units) and the histomorphometric exam.
Methodology: randomized and open clinical trial with 20 patients (10 per group: with or without ESWT treatment) that comply the inclusion and exclusion criteria. In the first appointment the tooth extraction will be performed, while in the second visit (two weeks later), CT scan will be made to all patients and ESWT will be applied in the experimental group. Finally, in the third visit (ten weeks later), a new CT scan will be done and an implant will be placed in the zone taking previously a bone sample with a trephine bur.
The expected results are an improvement in the quantity and quality of the alveolar bone before the implant placement.
- Conditions
- Loss of Teeth Due to Extraction, Bone Resorption
- Being tested
- Shockwave therapy
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave therapyDevice
A shockwave therapy device will be applied in the alveolar socket area of a maxillary tooth, 2 weeks after tooth extraction was performed.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave therapy | Experimental | After dental extraction, a shockwave therapy will be applied to the area. Receives: Device: Shockwave therapy |
| Control | No intervention | After dental extraction, no treatment will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume
Measured in Cone Beam Computer Tomography
Measured: 10 weeks
Histomorphometry
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The sctrict inclusion and exclusion criteria made the study unfeasible. No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Teeth Due to ExtractionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rui Figueiredo
- Sponsor type
- University, hospital or other
- Collaborators
- MTS Europe GmbH (sponsor)
- Responsible party
- Sponsor-investigator, Rui Figueiredo, University of Barcelona
- Investigators
- Rui Rui, DDS, MS, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331028
- Sponsor's protocol ID
- 496/14/EC
- Other IDs
- 496/14/EC, 15/2013
- Acronym
- Shockwave
- Status last verified
- Mar 2020
- First submitted
- 11 Dec 2014
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
- ClinicalTrials.gov ID
- NCT04331028
- Acronym / sponsor ID
- Shockwave / 496/14/EC
- Conditions
- Loss of Teeth Due to Extraction, Bone Resorption
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sctrict inclusion and exclusion criteria made the study unfeasible. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rui FigueiredoUniversity, hospital or other
- Collaborators
- MTS Europe GmbH (sponsor)
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2020 (actual)
- 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 extracorporeal shock wave therapy (ESWT) has shown good results in bones and soft tissues of the lower and upper extremities such as: pseudoarthrosis, promoting bone formation of delayed or nonunion fractures, tendinopathies, fascitis and even in vascular pathologies.
The investigators main hypothesis is that the application of extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth should prevent further residual alveolar bone resorption and will enhance vital bone formation.
The investigators null hypothesis is that applying extracorporeal shock wave therapy (ESWT) in the residual alveolar bone after an extraction of an anterior upper maxillary tooth has no influence in the alveolar bone remodeling process.
Therefore, the investigators main objective is to evaluate the efficacy of the ESWT in the prevention of alveolar bone resorption after an extraction with a volumetric exam through computer tomographies (CT) analysis. The investigators secondary objective is to determine the effect of ESWT in the internal bone healing process of these postextraction alveolar sockets, measuring the bone density in the CT (Hounsfield units) and the histomorphometric exam.
Methodology: randomized and open clinical trial with 20 patients (10 per group: with or without ESWT treatment) that comply the inclusion and exclusion criteria. In the first appointment the tooth extraction will be performed, while in the second visit (two weeks later), CT scan will be made to all patients and ESWT will be applied in the experimental group. Finally, in the third visit (ten weeks later), a new CT scan will be done and an implant will be placed in the zone taking previously a bone sample with a trephine bur.
The expected results are an improvement in the quantity and quality of the alveolar bone before the implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave therapy | Experimental | Device: Shockwave therapyAfter dental extraction, a shockwave therapy will be applied to the area. |
| Control | No intervention | –After dental extraction, no treatment will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages between 18 - 65 years old.
- Non-smoking patients.
- Patients committed to rehabilitate the extraction socket with an implant.
- Lack of pathology in the surrounding area.
- Cooperative patients with serious commitment to follow the investigator's postoperative visits, who must sign the informed consent.
Key exclusion criteria (10 listed)
- Systemic illnesses (ASA III or above) that could contraindicate a surgical intervention or modify the wound healing.
- Patients with cardiopathies.
- Patients taking hormones, calcium or oral or endovenous bisphosphonates.
- Patients with uncontrolled periodontitis / periimplantitis.
- Smokers.
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 |
|---|---|---|
| Shockwave therapyA shockwave therapy device will be applied in the alveolar socket area of a maxillary tooth, 2 weeks after tooth extraction was performed. | Device | Shockwave therapy |
Primary outcome
Bone volume
Time frame: 10 weeks
Measured in Cone Beam Computer Tomography
Histomorphometry
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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.
Rui Rui, DDS, MS, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave therapy in people with Loss of Teeth Due to Extraction and Bone Resorption, run by Rui Figueiredo 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Apr 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Bone volume (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 2 Apr 2020.