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CompletedNCT03202030IDRBio-ossUpdated May 11, 2022

Immediate Dentoalveolar Restoration Compared to Bio-oss

An interventional study of Immediate dentoalveolar restoration and Demineralized bovine bone in Fresh Sockets With Buccal Resorption, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Uruguay. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fresh Sockets With Buccal Resorption

Keywords

  • immediate dentoalveolar restoration
  • bio-oss
  • immediate dental implant
  • bovine bone
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Tooth extraction indicated for teeth in anterior area between second premolars

Exclusion criteria

Exclusion Criteria:

  • Diabetes and other systemic conditions that may affect osseointegration
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    IDR

    Immediate dentoalveolar restoration conducted with bone removed from the tuber

    Procedure: Immediate dentoalveolar restoration

  • Active comparator
    Bio-oss

    Bovine demineralized bone (Bio-oss Collagen) applied on the buccal resorption of the immediate implant

    Procedure: Demineralized bovine bone

Interventions

  • ProcedureImmediate dentoalveolar restoration

    Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant

    Also known as: IDR

  • ProcedureDemineralized bovine bone

    Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant

05

What researchers measure

Primary outcomes

  1. Buccal-palatal thickness

    Time frame: 18 months

Secondary outcomes

  1. Oral-health related quality of life

    The OHIP-14 will be applied and satisfaction will also be recorded

    Time frame: 18 months

06

Study locations

1 site
  • Universidad de La Republica del Uruguay
    Montevideo, Uruguay
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03202030
Lead sponsor
Federal University of Rio Grande do Sul
Collaborators
University of the Republic, Uruguay
Responsible party
Alex Nogueira Haas (Professor, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Jun 28, 2017
Start date
Jan 2016
Primary completion
Dec 2018
Completion
Jan 2020
Last update
May 11, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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