Clinical trial NCT04331028: Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
Official title: Effect of Shock-wave Therapy on the Resorption and Bone Formation in Maxillary Postextraction Sockets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Loss of Teeth Due to Extraction
Bone Resorption
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: MTS Europe GmbH (sponsor)
First posted: 2020-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Bone volume
timeFrame: 10 weeks
measure: Histomorphometry
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Odontologic
state: Barcelona
Study officials:
affiliation: University of Barcelona
name: Rui Rui, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: