Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06226116 |
| Other study ID # |
ULE-034-2018 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Universidad de León |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The healing process after tooth removal involves bone remodelling which implies some loss of
alveolar bone volume.Among materials proposed for minimising this remodelling and preserving
the bone, autologous dental tissue is a promising option, but more data are needed. In this
context, the investigator evaluated size and density changes using cone beam computed
tomography in autologous dental material (ADM)-preserved sockets compared to controls,and
assessed biological responses by histological analysis of bone implant contact (BIC) an Area
density (AA) using experimental Bioetch® surface implant.
Description:
30 patients will be selected for the study, based on the inclusion/exclusion criteria and the
clinical judgment of the investigator. Prior to enrollment, all subjects will be asked sign
an informed consent form to demonstrate that the patient understand the scope of the study
(including surgical interventions and the potential risks involved), allowing the opportunity
to ask questions related to the study and giving information about treatments alternatives.
Inclusion criteria:
Partially or totally edentulous patients for whom treatment is indicated. At least 18 years
of age, of both sexes and of any race. That the the participants understand that are involved
in the study, including the visit requirements of follow-up.
With 6 mm or more bone width, which will be sufficient to place a cylindrical implant with 2
mm Bioetch® surface. in diameter and 8 mm of length. After 16 weeks explantation will be
performed for the study, followed by placement of a wider implant.
Exclusion criteria:
Smokers. Pregnancy. History of uncontrolled systemic disease or chronic diseases. Coagulation
disorder or taking anticoagulants. Treatment with bisphosphonates. Subjects with severe
compromise of the immune system. History of mental instability that hinders participation in
the study. Other conditions that the investigator may feel the patient is not a good
candidate for this study (e.g., alcoholism, drug addiction).
Implant material: 2 mm diameter and 8 mm. of length cylinders will be used in the study. The
body will be threaded with a pitch of 0.25mm. and with Bioetch® subtraction surface. The
cylinders will be placed after the passage of the milling cutter. Lance and the 1.8 mm
diameter. The implant enters the bed because its head It is machined with a knurled key
figure that adjusts the universal screwdriver.
After 16 weeks, the study cylinders will be explanted with a trephine drill. Internal
diameter 4 mm and external 4.5 mm which, in most cases, ensures recovery of the cylinder with
osseointegrated material around it along its entire length.
Next, the trephine bur, with the material inside, is placed in formaldehyde buffered at 10%
for transfer to the laboratory.
The patient will receive a 5 mm implant. in diameter, to rehabilitate the area where it has
been collected the sample.
3 - Histological methodology: The collected sample will be placed in buffered formalin and
then sent to the Histology laboratory, Anatomy section of the Department of Surgery, Medical
Sciences and Social Services of the University of Alcala, for processing. This will be done
in the following way:
1. Inclusion of the sample in plastic polymers of tissue section.
2. Histological preparations with undecalcified bone sections and with the implant
included.
3. Cutting the samples with the EXACT system. Histological study of the sections with the
description and differentiation of bone tissue in each sample.
4. Staining of the sections with toluidine blue, hematoxylin-eosin and/or trichrome.
5. Evaluation of the presence or absence of inflammatory reaction or foreign body reaction.
6. Histomorphometric study of the sample based on the morphology of the surface of the
implant. The sample will be evaluated with the MIP-4 program evaluating the percentage
of osseointegration (BIC), taking into account the area around the implant.
7. Statistical study to evaluate differences between the two types of samples with test
analysis of variance (ANOVA).
