EMD for Treatment of Proximal Class-II Furcation Involvements

Study Overview
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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).

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.

Official Title
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Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial

Conditions
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Generalized Aggressive Periodontitis

Intervention / Treatment
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* Procedure: Enamel matrix derivative proteins
* Procedure: Open Flap debridement


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enamel matrix derivative proteins<br>Open flap debridement to enamel matrix derivative application in proximal class-II furcation. | Procedure: Enamel matrix derivative proteins<br>* Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.<br>* Other names: Surgical therapy;Procedure: Open Flap debridement<br>* Open flap debridement will be performed to decontaminate the proximal furcation involvements.<br>* Other names: Surgical therapy;|
| Active Comparator: Open Flap Debridement<br>Open flap debridement in proximal class-II furcation. | Procedure: Open Flap debridement<br>* Open flap debridement will be performed to decontaminate the proximal furcation involvements.<br>* Other names: Surgical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Horizontal clinical attachment level | horizontal component of the defect | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enamel matrix derivative, proximal furcation, randomized clinical trial