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mp3 vs Apatos in Post-extractive Sockets

NCT02644070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-15

No results posted yet for this study

Summary

The primary aim of the present multicenter randomized controlled trial was to evaluate and compare the shortterm clinical and histological changes of extraction sockets after ridge preservation procedures with changes of extraction sockets that healed naturally.

The secondary aim was to evaluate which, if any extraction socket characteristics could have affected tissue changes occurring at the augmented as well as naturally healed sites.

Recruitment and enrollment of patients were performed from June 2011 to June 2012 in five university centers/private practice:

* University of Pisa;
* University of Murcia;
* University of Ancona;
* Private practice, Dr. Di Felice;
* University of Verona.

Randomization:

1. extraction sockets with spontaneous healing;
2. extraction sockets grafted with pre-hydrated collagenated cortico-cancellous porcine bone, with a particle size between 600 and 1000 μm;
3. extraction sockets grafted with cortical porcine bone, with a particle size between 600 and 1000 μm.

Outcome Variables

* Complications
* Changes of ridge volume contour;
* Vertical bone changes;
* Buccal-Lingual Width;
* Histomorphometric parameters.

Sample size was calculated comparing outcome data between grafted sockets versus non-grafted sockets. The primary parameter was the change in mid-buccal vertical height (0.7±1.4mm and 3.6±1.5mm, respectively, for the test and control groups) (Barone et al. 2008). Final sample size was increased to 30 subjects per group due to possible patient dropout events. Each center contributed according to the predetermined 1:1:1 ratio; the fresh extraction socket was considered the unit of randomization.

Corrections for balancing the three experimental groups for confounding factors were not applied.

A matrix elaborator performed all the analyses§§: multi-way analysis of variance (ANOVAn) was applied, then appropriate post hoc comparison tests were run; post hoc estimated effect sizes were calculated with a power of 0.9. The level of statistical significance was set at 0.05 for all analyses.

Conditions

  • Alveolar Bone Loss

Interventions

DEVICE

alveolar bone preservation with mp3

graft with corticocancellous porcine bone and collagen (MP3, Osteobiol, Coazze, Italy)

DEVICE

alveolar bone preservation with apatos

graft with cortical porcine bone (Apatos, Osteobiol, Coazze, Italy )

DEVICE

stabilization with membrane

socket stabilization with a collagen membrane (Evolution, Osteobiol, Coazze, Italy)

Sponsors & Collaborators

  • Tuscan Dental Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

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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 NCT02644070 on ClinicalTrials.gov