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.

Not Applicable

• Conditions: Gingival Recession
• Interventions: Device: The tunnel technique for root coverage without Emdogain; Device: The tunnel technique for root coverage with Emdogain

• Registration Number: NCT03354104
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Status Verified: 2018-01
• Study Start: 2018-01-22
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-24
• Primary Completion: 2019-01-05
• Study Completion: 2019-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recession coverage with connective tissue graft	The tunnel technique for root coverage without Emdogain	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.
Recession coverage with connective tissue graft + Emdogain®	The tunnel technique for root coverage with Emdogain	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.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	6 months after surgery	Distance from the cementoenamel junction to the bottom of the gingival sulcus

Secondary Outcome Measures

Name	Time	Method
Recession height (RH)	6 months after surgery	Distance from the cementoenamel junction to the gingival margin
Recession width (RW)	6 months after surgery	Distance measured horizontally at cementoenamel junction level from one border of the recession to another
Width of keratinized tissue (WKT)	6 months after surgery	Distance between the most apical point of the gingival margin and the mucogingival junction
Thickness of keratinized tissue (TKT)	6 months after surgery	Thickness of the gingiva measured 2 mm apical to the gingival margin
Average recession coverage (ARC)	6 months after surgery	The percentage of covered recession area
Complete recession coverage	6 months after surgery	The percentage of sites with complete root coverage

Trial Locations

Locations (1)

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw; 🇵🇱 Warsaw, Mazowsze, Poland