Horizontal Ridge Augmentation in Mandible Usign ROG + ESWT

NCT03785717 | Completed

• 1 other identifier: PCI2015-8351
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge deficiencies, allowing to restore such defects in order to place bone-integrated dental implants. A few reports exist in the literature about the augmentation of mandibular horizontal ridge defects before implant placement. Published studies show a large variability of reported results regarding horizontal bone augmentation. This can be due to the use of different types of membranes and bone graft materials or a combination thereof. Likewise, an important percentage of graft reabsorption is reported. Although this technique is very much used, an important number of cases must be re-treated or require placing bone graft during implant installation surgery. Techniques are required in order to improve vascularization of the grafts during GBR technique with the aim to improve their clinical success. Recent studies show great interest on the application of shock waves in oral diseases associated to infection and bone loss. The shock waves are acoustic waves that have effects on human biological tissues, stimulating the neo-angiogenesis and the development of a hyper cellularity, showing repairing characteristics on tissues, and starting regenerative processes as a result of metabolism improvement and the increase of local circulation. The extra corporeal shock waves can activate the osteoblasts and their precursors and they have been widely used in orthopaedics for repairing bone fractures. Several clinical studies have shown the effectiveness and safety of shock wave therapy in myocardial revascularization, lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated injuries of soft tissues. No clinical studies exist that assess its effect on guided bone regeneration. The evidence related to the positive effects of the use of shock waves on bone regeneration suggests this treatment as a novelty and a promising therapy that combined with the GBR technique for the treatment of horizontal defects could have an important impact on the potentialization of its clinical effectiveness.

Conditions

Bone Regeneration

Keywords

shock wave therapy (SWT or ESWT); Guided bone regeneration (GBR); horizontal ridge augmentation

Outcome Measures

Primary Outcomes (1)

• Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.

  Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.

  Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.

Study Arms (2)

ROG only

ACTIVE COMPARATOR

cancellous (1-2 mm) \& cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy

Procedure: ROG; Procedure: ROG & ESWT

ROG & ESWT

ACTIVE COMPARATOR

cancellous 1-2mm \& cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy

Procedure: ROG; Procedure: ROG & ESWT

Interventions

ROG PROCEDURE

Bone width augmentation using bone grafting and membrane non cross linking.

ROG & ESWT; ROG only

ROG & ESWT PROCEDURE

Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).

ROG & ESWT; ROG only

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who agree to participate in the study and sign informed consent
• Partial mandibular edentulism requiring at least two teeth to be replaced with osseointegrated implants
• Patient with alveolar ridge thickness of ≤4mm, evaluated by CBCT
• Vertical bone availability of 9mm to anatomical structure such as a chin or dental canal that allows a short implant placement of 8mm at the end of the study.
• Extractions performed ≥ 6 months
• Elderly patients between 35 and 65 years old
• Patients without current disease or with chronic pathologies in medical control that does not affect the healing processes such as: controlled hypertension, controlled hypothyroidism, controlled hypercholesterolemia
• Evaluated by anamnesis and laboratory tests that rule out processes of immunosuppression, glycemia and coagulation disorders hypercholesterolemia
• No smoking

You may not qualify if:

• Diabetes
• Immunosuppressive drugs
• Anti-coagulated or with dual anti-platelet aggregation
• Therapy with bisphosphonates
• Hormone replacement therapy
• Patient with a history of radiotherapy of the head and neck
• Pregnant women or nursing
• Permanent consumption of NSAIDs and corticosteroids
• Prolonged antibiotic therapy in the last 6 months

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead
• Gloria Lafaurie: collaborator
• Carlos Leal: collaborator

Study Sites (1)

Yamil Lesmes

Bogotá, Colombia

Location

MeSH Terms

Conditions

Ciliary Dyskinesia, Primary, 13

Study Officials

• Yamil Lesmes

  Universidad El Bosque

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc candidate

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: December 24, 2018
• Study Start: August 1, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 20, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

CO (1)