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.

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.

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.

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Device: The tunnel technique for root coverage with Emdogain; Device: The tunnel technique for root coverage without Emdogain

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowsze
    • Warsaw, Mazowsze, Poland, 00-246
      • Recruiting
      • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recession coverage with connective tissue graft + 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.	Device: The tunnel technique for root coverage with Emdogain; The tunnel technique for root coverage with Emdogain
Active Comparator: Recession coverage with connective tissue graft; 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; The tunnel technique for root coverage without Emdogain

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PPD)	Distance from the gingival margin to the bottom of the gingival sulcus	6 months after surgery
Root coverage esthetic score (RES)	A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)	6 months after surgery
Post surgical pain and swelling	Questionnaire about post surgical pain and swelling using a Visual Analog Scale with values 0 (no pain / swelling), 1, 2, 3, 4, 5(moderate pain/swelling), 6, 7, 8, 9, 10 (worst pain / swelling). Lower values represent lower post surgical discomfort and are considered better.	1, 2, 4, 7 and 14 days after surgery
Patient's satisfaction with treatment	Questionnaire about patient's esthetic perception of gingiva and overall satisfaction using a Visual Analog Scale from 0 (dissatisfaction with esthetic outcome), 2, 3, 4, 5 (moderate satisfaction with easthetic outcome), 6, 7, 8, 9, 10 (best satisfaction with esthetic outcome). Higher values are considered better.	6 months after surgery

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General Publications

• Gorski B, Szerszen M, Kaczynski T. Effect of 24% EDTA root conditioning on the outcome of modified coronally advanced tunnel technique with subepithelial connective tissue graft for the treatment of multiple gingival recessions: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):1761-1772. doi: 10.1007/s00784-021-04151-9. Epub 2021 Aug 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Anticipated): January 5, 2019
• Study Completion (Anticipated): May 5, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: WUM.PERIO.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No