Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2018-06-01

Brief Summary

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The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.

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Detailed Description

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Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.

Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Root Instrumentation + EMD Application

Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.

In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.

Group Type EXPERIMENTAL

Root Instrumentation

Intervention Type PROCEDURE

Instrumentation of the root surface in order to achieve debridement

EMD Application

Intervention Type DEVICE

Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm

Root Instrumentation

Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.

Group Type ACTIVE_COMPARATOR

Root Instrumentation

Intervention Type PROCEDURE

Instrumentation of the root surface in order to achieve debridement

Interventions

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Root Instrumentation

Instrumentation of the root surface in order to achieve debridement

Intervention Type PROCEDURE

EMD Application

Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Good health
* No previous periodontal treatment
* Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
* Ability to understand the study procedures and comply with them through the length of the study

Exclusion Criteria

* Pregnancy and breast feeding
* Need for antibiotic treatment during periodontal therapy
* Chronic infections
* Systemic diseases
* Patients who report current smoking over 20 cigarettes per day

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No