Immediate Dentoalveolar Restoration Compared to Bio-oss

Overview

This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.

Full Title of Study: “Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 2018

Interventions

  • Procedure: Immediate dentoalveolar restoration
    • Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant
  • Procedure: Demineralized bovine bone
    • Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant

Arms, Groups and Cohorts

  • Experimental: IDR
    • Immediate dentoalveolar restoration conducted with bone removed from the tuber
  • Active Comparator: Bio-oss
    • Bovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant

Clinical Trial Outcome Measures

Primary Measures

  • Buccal-palatal thickness
    • Time Frame: 18 months

Secondary Measures

  • Oral-health related quality of life
    • Time Frame: 18 months
    • The OHIP-14 will be applied and satisfaction will also be recorded

Participating in This Clinical Trial

Inclusion Criteria

  • Tooth extraction indicated for teeth in anterior area between second premolars Exclusion Criteria:
  • Diabetes and other systemic conditions that may affect osseointegration
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Federal University of Rio Grande do Sul
    • Collaborator
      • University of the Republic, Uruguay
    • Provider of Information About this Clinical Study
      • Principal Investigator: Alex Nogueira Haas, Professor – Federal University of Rio Grande do Sul
    • Overall Contact(s)
      • Alex Haas, PhD, +555133085318, alexnhaas@gmail.com

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