NCT03202030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

June 26, 2017

Last Update Submit

May 9, 2022

Conditions

Fresh Sockets With Buccal Resorption

Keywords

immediate dentoalveolar restorationbio-ossimmediate dental implantbovine bone

Outcome Measures

Primary Outcomes (1)

  • Buccal-palatal thickness

    18 months

Secondary Outcomes (1)

  • Oral-health related quality of life

    18 months

Study Arms (2)

IDR

EXPERIMENTAL

Immediate dentoalveolar restoration conducted with bone removed from the tuber

Procedure: Immediate dentoalveolar restoration

Bio-oss

ACTIVE COMPARATOR

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

Procedure: Demineralized bovine bone

Interventions

Immediate dentoalveolar restorationPROCEDURE

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
IDR
Demineralized bovine bonePROCEDURE

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

Bio-oss

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes and other systemic conditions that may affect osseointegration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de La Republica del Uruguay

Montevideo, Uruguay

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 28, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2020

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

UR(1)