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Regenerative Combined Therapy With Enamel Matrix Derivative and Biphasic Calcium Phosphate Graft

NCT02828423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-07-11

No results posted yet for this study

Summary

Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained defects may be limited, as EMD does not maintain a space itself. It has been proposed the use of combined therapy, using a bone graft in combination with EMD to avoid the collapse of the flap into the bony defect during the healing time. Therefore the aim of this study is to evaluate the clinical and radiological healing response of non-contained infrabony defects following treatment with a combination of EMD and Biphasic calcium phosphate (BC) or EMD alone.

Methods: Fifty-two patients with at least 1 infrabony defect \> 3mm in depth with a probing pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the procedure an acrylic stent and a millimetre radiographic grid were used. The primary outcome was the change in clinical attachment level (CAL).

Results: Analysis of the data demonstrated a statistically significant difference from baseline within each group (p\<0.05), showing a difference in clinical and radiographic parameters at 6 and 12 months for both EMD/BC and EMD alone. However, there were no statistically significant differences between treatment groups.

Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD, with or without BC, resulted in statistically significant better results after 12 months when compared to baseline measurements. In contrast, the combined approach did not result in a statistically significant improvement.

Conditions

  • Intrabony Periodontal Defect

Interventions

PROCEDURE

EMD

Regenerative surgery with EMD

PROCEDURE

BC

Regenerative surgery with BC

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • José Nart, PhD, DDS, MS · Universitat Internacional de Catalunya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-02-29
Completion
2016-03-31

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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 NCT02828423 on ClinicalTrials.gov