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

NCT04331028 | Withdrawn

• 2 other identifiers: 496/14/EC15/2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Loss of Teeth Due to Extraction; Bone Resorption

Outcome Measures

Primary Outcomes (2)

• Bone volume

  Measured in Cone Beam Computer Tomography

  10 weeks

• Histomorphometry

  10 weeks

Study Arms (2)

Shockwave therapy

EXPERIMENTAL

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

Device: Shockwave therapy

Control

NO INTERVENTION

After dental extraction, no treatment will be applied

Interventions

Shockwave therapy DEVICE

A shockwave therapy device will be applied in the alveolar socket area of a maxillary tooth, 2 weeks after tooth extraction was performed.

Shockwave therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rui Figueiredo: lead
• MTS Europe GmbH (sponsor): collaborator

Study Sites (1)

Hospital Odontologic

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Bone Resorption

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rui Rui, DDS, MS, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor; IDIBELL researcher

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: April 2, 2020
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

ES (1)