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.

Study Overview
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Brief Summary
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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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: The tunnel technique for root coverage with Emdogain
* Device: The tunnel technique for root coverage without Emdogain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recession coverage with connective tissue graft + Emdogain®<br>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. | Device: The tunnel technique for root coverage with Emdogain<br>* The tunnel technique for root coverage with Emdogain<br>|
| Active Comparator: Recession coverage with connective tissue graft<br>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. | Device: The tunnel technique for root coverage without Emdogain<br>* The tunnel technique for root coverage without Emdogain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level (CAL) | Distance from the cementoenamel junction to the bottom of the gingival sulcus | 6 months after surgery | 

Secondary Outcome Measures

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