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Evaluation of a Synthetic Bone Substitute for Ridge Preservation

NCT02894528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-11-13

No results posted yet for this study

Summary

Fifteen patients were selected, each presenting at least two jaw front teeth indicated for extraction: in the Test Group (TG), post-extraction sockets was filled by synthetic bone substitute ReproBone, and in the Control Group (CG) the socket was filled only by clot. In both groups, the sockets were covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap. Computed tomography scans were acquired in the immediate postoperative period and 6 months after surgery, and the horizontal and vertical dimensional changes in bone crests were quantified.

Conditions

  • Alveolar Process

Interventions

DRUG

BioMend and ReproBone

Post-extraction sockets was filled by synthetic bone substitute ReproBone, and after the sockets were covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap.

DRUG

BioMend without ReproBone

Post-extraction the socket was filled only by clot and covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Sérgio S de Souza, Dr · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-03-31
Completion
2015-01-31

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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 NCT02894528 on ClinicalTrials.gov