EMD for Treatment of Proximal Class-II Furcation Involvements

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2019-05-20

Brief Summary

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The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).

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Detailed Description

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Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.

Conditions

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Generalized Aggressive Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Enamel matrix derivative proteins

Open flap debridement to enamel matrix derivative application in proximal class-II furcation.

Group Type ACTIVE_COMPARATOR

Enamel matrix derivative proteins

Intervention Type PROCEDURE

Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.

Open Flap debridement

Intervention Type PROCEDURE

Open flap debridement will be performed to decontaminate the proximal furcation involvements.

Open Flap Debridement

Open flap debridement in proximal class-II furcation.

Group Type ACTIVE_COMPARATOR

Open Flap debridement

Intervention Type PROCEDURE

Open flap debridement will be performed to decontaminate the proximal furcation involvements.

Interventions

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Enamel matrix derivative proteins

Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.

Intervention Type PROCEDURE

Open Flap debridement

Open flap debridement will be performed to decontaminate the proximal furcation involvements.

Intervention Type PROCEDURE

Other Intervention Names

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Surgical therapy Surgical therapy

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
* Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
* Presence of one proximal class-II furcation presenting probing depth \> 4 mm and bleeding on probing ;
* Good general health;
* Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

Exclusion Criteria

* Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
* Have used antibiotics and anti-inflammatories in the last six months;
* Smoke ≥ 10 cigarettes/day;
* Pregnant or lactating;
* Chronic use of medications that may alter the response of periodontal tissues;
* Indication of antibiotic prophylaxis for dental procedures;

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes