EMD for Treatment of Proximal Class-II Furcation Involvements

Not Applicable

Completed

• Conditions: Generalized Aggressive Periodontitis
• Interventions: Procedure: Enamel matrix derivative proteins; Procedure: Open Flap debridement

• Registration Number: NCT03320135
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Primary Completion: 2018-10-20
• Study Completion: 2019-05-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enamel matrix derivative proteins	Open Flap debridement	Open flap debridement to enamel matrix derivative application in proximal class-II furcation.
Open Flap Debridement	Open Flap debridement	Open flap debridement in proximal class-II furcation.
Enamel matrix derivative proteins	Enamel matrix derivative proteins	Open flap debridement to enamel matrix derivative application in proximal class-II furcation.

Primary Outcome Measures

Name	Time	Method
Horizontal clinical attachment level	1 year	horizontal component of the defect

Trial Locations

Locations (1)

Naira Andere; 🇧🇷 São José dos Campos, SP, Brazil