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Regeneration of Alveolar Sockets With rhBMP-2-loaded Bovine Bone Mineral

NCT05717478 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-12

No results posted yet for this study

Summary

Aim of the present investigation will be to evaluate the efficacy and safety of a granulate of rhBMP-2- loaded bovine bone mineral (rhBMP-2-BBM) as alveolar bone regeneration procedure following tooth extraction.

Forty (40) patients (both sex; age 18 years and older) requiring extraction of one (1) hopeless tooth (incisor, canine or premolar with loss of bone height of 5 mm or more in buccal alveolar wall), followed by alveolar bone regeneration (ABR) and placement of an endosteal implant will be enrolled into the study.

After exodontia, participants will be randomized and divided into two groups: in Experimental Group the socket will be grafted with rhBMP-2-BBM granules (1.0-0.25 mm); in Control Group the sockets will be grafted with Bio-Oss granules (1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide).

The end of the study will be fixed at the implantation surgery, seventeen (17) weeks after exodontia an ABR. Cone beam computed tomography (CBCT) scans will be made, immediately after (0), and sixteen (16) weeks after exodontia an ABR and the gain in alveolar bone height will be estimated and used as the primary outcome for comparison of both groups.

As secondary efficacy outcomes the change in alveolar bone width estimated from the CBCT scans; initial (0) and at seventeenth (17th) week after tooth extraction; the change in dental arch dimensions estimated from tridimensional models obtained from intraoral scans at one week before (-1) and sixteen (16) weeks exodontia an ABR; and the amounts of new bone, remnant material and connective tissue histomorphometrically measured in a bone biopsy collected during the implantation surgery at seventeenth (17th) week, will be considered.

Healing of gingival tissues at first (1st) and second (2nd) week and incidence of adverse reactions at first (1st), second (2nd) and sixteenth (16th) week, are used as secondary safety outcomes.

Conditions

  • Loss of Teeth Due to Extraction
  • Alveolar Bone Loss
  • Edentulous Alveolar Ridge

Interventions

COMBINATION_PRODUCT

rhBMP-2-BBM

Alveolar socket is filled with granules of bovine bone mineral (1.0-0.25 mm) loaded with human recombinant bone morphogenetic protein 2

DEVICE

Bio-Oss+Bio-Gide

Alveolar socket is filled with granules of bovine bone mineral (Bio-Oss 1.0-0.25 mm) and covered with porcine collagen barrier membrane (Bio-Gide)

Sponsors & Collaborators

  • NORICUM SL

    collaborator UNKNOWN

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Mariano Sanz, MD,PHD · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-09-15
Completion
2024-09-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717478 on ClinicalTrials.gov