Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456337

Enrollment

Registered

2015-05-28

Start date

2014-07-31

Completion date

2016-10-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

Gingival Recession, Coronally advanced flap, Periodontal regeneration

Brief summary

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.

Interventions

DEVICEMucograft

Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.

DEVICEEmdogain

Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.

PROCEDURECoronally Advanced flap

Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years. * 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

* Smoking. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Recession Reduction	6 months	Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.

Secondary

Measure	Time frame	Description
Complete root coverage	6 months	Assessed as percentage of sites with complete root coverage

Other

Measure	Time frame	Description
Keratinized tissue thickness	6 months	Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026