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Evaluation of Enamel Matrix Derivative as an Adjunct to Minimally Invasive Non-surgical Treatment of Intrabony Defects.

NCT03622255 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-11

No results posted yet for this study

Summary

Aim:

The aim of this prospective, randomized, parallel arm, blind, controlled clinical trial is to compare the clinical and radiographic outcomes following regenerative treatment of intrabony periodontal defects using a Minimally Invasive Non-Surgical Technique (MINST) with or without the application of Enamel Matrix Derivative (EMD)

Research Hypothesis:

The hypothesis is that the adjunctive application of EMD will enhance the clinical and radiographic results of minimally invasive non- surgical treatment of intrabony defects. Radiographic bone fill will be the primary outcome of the research, whereas CAL gain and PD reduction will constitute the secondary outcomes.

Conditions

  • Periodontal Diseases

Interventions

PROCEDURE

MINST

Minimally invasive non-surgical technique (MINST) for the treatment of intrabony defects has been compared with minimally invasive surgical treatment of these defects and has shown to achieve similar beneficial clinical results. In this study MINST will be used as the control treatment.

PROCEDURE

MINST with EMD

Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal intrabony defects, using a minimally invasive surgical technique (MINST). Recent studies have suggested that this product could also be used in the non-surgical treatment of intrabony defects using a minimally invasive technique with very good results. This study will evaluate the effect of enamel matrix derivative in the non-surgical treatment of periodontal intrabony defects when a minimally invasive technique is used. Besides clinical measurements, radiographic analysis will also be performed to evaluate the treatment results.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Ioannis Vouros, DDS, Ph.D · Aristotle University Of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-05
Primary Completion
2021-03-15
Completion
2021-03-15

Countries

  • Greece

Study Locations

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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 NCT03622255 on ClinicalTrials.gov