Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival Recessions: a Randomized Clinical Trial.

Medical University of Warsaw

Status: Unknown

Conditions: Gingival Recession

Treatments: Device: The tunnel technique for root coverage with Emdogain; Device: The tunnel technique for root coverage without Emdogain

Study type: Interventional

Funder types: Other

Identifiers

NCT03354104

WUM.PERIO.01

Details and patient eligibility

About

Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Enamel matrix derivatives (EMD) can be used as an alternative to the aforementioned gold standard. The aim of this study is to evaluate clinically the use of tunnel technique with EMD applied group in addition to CTG and the same technique with CTG group for the treatment of multiple gingival recessions.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Bilateral multiple gingival recessions in homologous teeth

Exclusion criteria

• Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
• Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
• Smoking
• Systemic diseases with compromised healing potential of infectious diseases
• Drugs affecting periodontal health / healing
• Pregnant and lactating females
• Previous periodontal surgery in the area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Recession coverage with connective tissue graft + Emdogain®

Experimental group

Description:

A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The root surfaces are applied with 24% EDTA (PrefGel®, Straumann, Basel, Switzerland) for 2 minutes and then washed with saline. Subsequently, EMD (Emdogain®, Straumann, Basel, Switzerland) is applied on root surfaces. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

Treatment:

Device: The tunnel technique for root coverage with Emdogain

Recession coverage with connective tissue graft

Active Comparator group

Description:

Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

Treatment:

Device: The tunnel technique for root coverage without Emdogain