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

NCT06226116 | Unknown

• 1 other identifier: ULE-034-2018
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Resorption; Bone Regeneration

Keywords

bone implant contact; autologous dentin; socket preservation; bone density area

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

socket preservation with autologous dentin

EXPERIMENTAL

Procedure: socket preservation; Procedure: placement of experimental implants; Procedure: histological sample collection

extract teeth socket

PLACEBO COMPARATOR

only stabilized blood clot

Procedure: placement of experimental implants; Procedure: histological sample collection

Interventions

socket preservation PROCEDURE

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.

socket preservation with autologous dentin

placement of experimental implants PROCEDURE

After four months of preservation, titanium cylinders measuring 2 mm wide by 8 mm long, with a Bioetch® surface, will be placed.

extract teeth socket; socket preservation with autologous dentin

histological sample collection PROCEDURE

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.

extract teeth socket; socket preservation with autologous dentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de León: lead

Study Sites (1)

centro odontológico de formación integral de León

León, 24004, Spain

Location

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of master bucal surgery, implantology and periodontology

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 26, 2024
• Study Start: January 1, 2018
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)