EMD for Treatment of Proximal Class-II Furcation Involvements
OFD
Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
1 other identifier
interventional
34
1 country
1
Brief Summary
The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2017
CompletedStudy Start
First participant enrolled
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2019
CompletedJune 5, 2019
June 1, 2019
1 year
October 20, 2017
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Horizontal clinical attachment level
horizontal component of the defect
1 year
Study Arms (2)
Enamel matrix derivative proteins
ACTIVE COMPARATOROpen flap debridement to enamel matrix derivative application in proximal class-II furcation.
Open Flap Debridement
ACTIVE COMPARATOROpen flap debridement in proximal class-II furcation.
Interventions
Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Naira Andere
São José dos Campos, São Paulo, 12245010, Brazil
Related 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 Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.
PMID: 18341602RESULT
Study Officials
- STUDY DIRECTOR
Mauro M Santamaria, DDS, PhD
Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS,MS,PhD
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 25, 2017
Study Start
October 20, 2017
Primary Completion
October 20, 2018
Study Completion
May 20, 2019
Last Updated
June 5, 2019
Record last verified: 2019-06