EMD for Treatment of Proximal Class-II Furcation Involvements

Generalized Aggressive Periodontitis Clinical Trial

— OFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320135
• Other study ID #: UEPJMF ICT
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: June 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 20, 2019
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Aggressive Periodontitis
• Generalized Aggressive Periodontitis
• Periodontitis

Intervention

Procedure:
• Enamel matrix derivative proteins
Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
• Open Flap debridement
Open flap debridement will be performed to decontaminate the proximal furcation involvements.

Locations

Country	Name	City	State
Brazil	Naira Andere	São José dos Campos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horizontal clinical attachment level	horizontal component of the defect	1 year