search
Back to results

Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets (Shockwave)

Primary Purpose

Loss of Teeth Due to Extraction, Bone Resorption

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Shockwave therapy
Sponsored by
Rui Figueiredo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loss of Teeth Due to Extraction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Hospital Odontologic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shockwave therapy

Control

Arm Description

After dental extraction, a shockwave therapy will be applied to the area.

After dental extraction, no treatment will be applied

Outcomes

Primary Outcome Measures

Bone volume
Measured in Cone Beam Computer Tomography
Histomorphometry

Secondary Outcome Measures

Full Information

First Posted
December 11, 2014
Last Updated
April 1, 2020
Sponsor
Rui Figueiredo
Collaborators
MTS Europe GmbH (sponsor)
search

1. Study Identification

Unique Protocol Identification Number
NCT04331028
Brief Title
Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
Acronym
Shockwave
Official Title
Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The sctrict inclusion and exclusion criteria made the study unfeasible. No patients were enrolled.
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rui Figueiredo
Collaborators
MTS Europe GmbH (sponsor)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Teeth Due to Extraction, Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shockwave therapy
Arm Type
Experimental
Arm Description
After dental extraction, a shockwave therapy will be applied to the area.
Arm Title
Control
Arm Type
No Intervention
Arm Description
After dental extraction, no treatment will be applied
Intervention Type
Device
Intervention Name(s)
Shockwave therapy
Intervention Description
A shockwave therapy device will be applied in the alveolar socket area of a maxillary tooth, 2 weeks after tooth extraction was performed.
Primary Outcome Measure Information:
Title
Bone volume
Description
Measured in Cone Beam Computer Tomography
Time Frame
10 weeks
Title
Histomorphometry
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Rui, DDS, MS, PhD
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Odontologic
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets

We'll reach out to this number within 24 hrs