Atrophy of edentulous alveolar ridge
Conditions
Interventions
This is a two-arm, randomized controlled clinical trial with open masking, designed to compare two guided bone regeneration techniques involving bidirectional horizontal bone augmentation in patients
within 72 hours after the graft
6 months after the graft
and 1 year after implant loading. Measurements will be taken on the tomographic images by a single blinded examiner at three predetermined points from the alveolar crest, in order to assess horizontal
Sponsors
Instituto de Ciência e Tecnologia - Campus de São José dos Campos - Universidade Estadual Paulista
Instituto de Ciência e Tecnologia - Campus de São José dos Campos - Universidade Estadual Paulista
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Loss of three adjacent teeth in an atrophic alveolar ridge in the maxilla or mandible, according to the horizontal alveolar changes classification; need for bidirectional horizontal bone augmentation; residual bone height (minimum of 8 mm) at the surgical site; adequate oral hygiene; presence of 2 mm of keratinized tissue in the attached gingiva; aged between 18 and 75 years; both genders
Exclusion criteria
Exclusion criteria: Periodontal or peri-implant diseases; contraindications to surgical procedures; dental implants adjacent to the surgical site; smokers; diabetic patients; history of previous radiotherapy or chemotherapy; use of immunosuppressants, bisphosphonates, or corticosteroid therapy; pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the maintenance of bidirectional horizontal bone augmentation, as assessed by cone-beam computed tomography, will show a better prognosis in the Barbell technique group compared to the titanium-reinforced polytetrafluoroethylene membrane group, with 10% greater bone gain | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the following outcomes—assessment of the density and thickness of the newly formed bone using calibrated probing and a surgical bone gauge, with superior results in the Barbell technique, showing denser bone tissue in 5% of cases and greater thicknesses in 10%, similar to what was found in the tomographic analysis.;From the histomorphometric and micro-CT analysis of the grafted sites (to compare the newly formed bone and the remaining particles between the two techniques, including the presentation of their most relevant features), the Barbell group is expected to show superior performance, with more than 15% greater newly formed bone area, better tissue organization (predominance of lamellar bone), and a lower amount of remaining particles (10%), indicating greater remodeling and graft integration.;Comparison of the primary stability of implants placed in the grafted sites by means of insertion torque, with a 10% higher torque in the Barbell group.;Analysis of the clinical complications associated with each technique — with better outcomes expected in the group treated with the Barbell technique compared with the group treated with the titanium-reinforced polytetrafluoroethylene membrane, based on an anticipated 20% reduction in complications in the former group relative to those treated with the titanium-reinforced polytetrafluoroethylene membrane. | — |
Countries
Brazil
Contacts
Public ContactFernanda Costa
Instituto de Ciência e Tecnologia - Campus de São José dos Campos - Universidade Estadual Paulista
Outcome results
None listed