COMPARATIVE STUDY OF BONE IMPLANT CONTACT (BIC) ON NEW BONE REGENERATED WITH AUTOGENOUS DENTIN AND NATIVE BONE (BIC)

Comparative Study of Bone Implant Contact (BIC) With Experimental Bioecth® Surface Implant Between Native Bone and Regenerated Bone With Autogenous Dentine.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Resorption; Bone Regeneration
• Intervention / Treatment: Procedure: socket preservation; Procedure: placement of experimental implants; Procedure: histological sample collection

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • León, Spain, 24004
    • centro odontológico de formación integral de León

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 they understand that they 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: socket preservation with autologous dentin	Procedure: socket preservation; After the tooth extraction the investigator will select two sockets, one will be assigned as the experimental side and we will preserve it with cold-processed autologous dentin. The second will be designated the control group and we will only stabilize the blood clot.; Procedure: placement of experimental implants; After four months of preservation, titanium cylinders measuring 2 mm wide by 8 mm long, with a Bioetch® surface, will be placed.; Procedure: histological sample collection; Biopsy with trephine of a bone portion of 4mm in diameter and 10mm in length, which includes the titanium cylinder inside. Placement of conventional implant 5mm wide by 10mm long.
Placebo Comparator: extract teeth socket; only stabilized blood clot	Procedure: placement of experimental implants; After four months of preservation, titanium cylinders measuring 2 mm wide by 8 mm long, with a Bioetch® surface, will be placed.; Procedure: histological sample collection; Biopsy with trephine of a bone portion of 4mm in diameter and 10mm in length, which includes the titanium cylinder inside. Placement of conventional implant 5mm wide by 10mm long.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIC	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.	16 weeks after implant placement
AA Bone density area	evaluation of bone density in 0.25 mm around the experimental implant using the MIP-4 program	16 weeks after implant placement

Collaborators and Investigators

• Sponsor: Universidad de León

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: socket preservation; bone implant contact; autologous dentin; bone density area
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: ULE-034-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No