Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage
NCT ID: NCT02456337
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2014-07-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAF+MC+EMD
Coronally Advanced Flap with Mucograft and Emdogain
Mucograft
Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
Emdogain
Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.
Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
CAF+MC
Coronally Advanced Flap with Mucograft
Mucograft
Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
CAF+EMD
Coronally Advanced Flap with Emdogain
Emdogain
Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.
Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
CAF
Coronally Advanced Flap alone
Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mucograft
Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
Emdogain
Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.
Coronally Advanced flap
Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (\< 0.5 mm): A +(Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index ≤ 20% (Ainamo \& Bay 1975).
* Full-mouth sulcus bleeding index ≤ 20% (Mühlemann \& Son 1971).
Exclusion Criteria
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo
OTHER
University of Campinas, Brazil
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enilson Antonio Sallum
Professor. Department of Periodontics. Piracicaba Dental School. State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enilson A Sallum, PhD
Role: STUDY_CHAIR
University of Campinas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013/19473-6
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
067/2013
Identifier Type: -
Identifier Source: org_study_id