Maxillary Sinus
Conditions
Interventions
This project consists of a three-arm, double-blind, randomized, controlled trial in a parallel design. Thirty-six patients will be randomly allocated to groups according to the type of treatment to be
2) Test Group 1-1: Biphasic calcium material associated with enamel matrix protein at a concentration of 0.15 ml/g
3) Test Group 2: Biphasic calcium material associated with enamel matrix protein at a concentration of 0.30 ml/g. Patients will undergo surgical procedures for the insertion of the biomaterials, and a
Sponsors
Universidade Federal de Uberlândia
Universidade Federal de Uberlândia
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients with age be between 18 and 60 years; Patients who require unilateral or bilateral maxillary sinus floor elevation for subsequent placement of osseointegrated implants; Patients must have bone availability associated with the alveolar ridge adjacent to the maxillary sinus less than or equal to 3mm; Patients with good systemic health; Patients that present at least 4 months of post-extraction alveolar healing
Exclusion criteria
Exclusion criteria: Smokers; Uncontrolled diabetics; Patients with chronic or aggressive periodontitis; Patients using medications that alter bone metabolism; Patients with chronic upper respiratory tract infections; Patients who chronically use anti-inflammatory drugs and antibiotics; Patients with bruxism; Alcoholics; Substance abusers; Pregnant women or those wishing to become pregnant in the next year; History of radiotherapy treatment in the head and neck region; Patients with pathologies affecting bone metabolism; Patients who have experienced a large rupture of the sinus membrane during surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable of this study will be the percentage of bone formation in biopsies collected from the maxillary sinuses 4 months after the grafting procedure. It is expected to observe that in the groups where EMD will be apply, bone formation will be 10% greater than expected in the control group;The peri-implant bone level will be assessed using periapical radiographs and will be considered the primary outcome of this study. It is expected to observe that implants placed in the different types of grafted areas will not show differences in this parameter greater than 0.5 mm | — |
Secondary
| Measure | Time frame |
|---|---|
| The stability analysis of the implants will be one of the secondary variables in this study. It is expected to observe that implants placed in areas grafted with alloplastic bone substitute associated with EMD will show greater stability at 5 points compared to implants placed in areas grafted only with alloplastic bone substitute;The analysis of volume and linear gain of bone tissue in the grafted areas, which will be evaluated through tomographic analysis, will be one of the secondary outcomes of this study. It is expected to observe that the different treatments that will be apply in this study will not differ from each other, such that the differences in gain will be less than 5% between the groups in this study;The analysis of peri-implant parameters will be evaluated through clinical trials and will be considered secondary outcomes of this study. It is expected to observe that there will be no differences greater than 0.5 mm in probing depth and clinical attachment level parameters, and that there will be no differences greater than 5% in biofilm accumulation and peri-implant mucosal inflammation between the experimental groups of this study. | — |
Countries
Brazil
Contacts
Public ContactGuilherme Oliveira
Universidade Federal de Uberlândia
Outcome results
None listed