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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 Recessions: a Randomized Clinical Trial.

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
The tunnel technique for root coverage with Emdogain
The tunnel technique for root coverage without Emdogain
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Periodontology and Oral Mucosa Diseases, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recession coverage with connective tissue graft + Emdogain®

Recession coverage with connective tissue graft

Arm 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.

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.

Outcomes

Primary Outcome Measures

Clinical attachment level (CAL)
Distance from the cementoenamel junction to the bottom of the gingival sulcus

Secondary Outcome Measures

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

Full Information

First Posted
November 8, 2017
Last Updated
January 22, 2018
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03354104
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
January 5, 2019 (Anticipated)
Study Completion Date
May 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recession coverage with connective tissue graft + Emdogain®
Arm Type
Experimental
Arm 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.
Arm Title
Recession coverage with connective tissue graft
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
The tunnel technique for root coverage with Emdogain
Intervention Description
The tunnel technique for root coverage with Emdogain
Intervention Type
Device
Intervention Name(s)
The tunnel technique for root coverage without Emdogain
Intervention Description
The tunnel technique for root coverage without Emdogain
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
Distance from the cementoenamel junction to the bottom of the gingival sulcus
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Recession height (RH)
Description
Distance from the cementoenamel junction to the gingival margin
Time Frame
6 months after surgery
Title
Recession width (RW)
Description
Distance measured horizontally at cementoenamel junction level from one border of the recession to another
Time Frame
6 months after surgery
Title
Width of keratinized tissue (WKT)
Description
Distance between the most apical point of the gingival margin and the mucogingival junction
Time Frame
6 months after surgery
Title
Thickness of keratinized tissue (TKT)
Description
Thickness of the gingiva measured 2 mm apical to the gingival margin
Time Frame
6 months after surgery
Title
Average recession coverage (ARC)
Description
The percentage of covered recession area
Time Frame
6 months after surgery
Title
Complete recession coverage
Description
The percentage of sites with complete root coverage
Time Frame
6 months after surgery
Other Pre-specified Outcome Measures:
Title
Probing pocket depth (PPD)
Description
Distance from the gingival margin to the bottom of the gingival sulcus
Time Frame
6 months after surgery
Title
Root coverage esthetic score (RES)
Description
A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)
Time Frame
6 months after surgery
Title
Post surgical pain and swelling
Description
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.
Time Frame
1, 2, 4, 7 and 14 days after surgery
Title
Patient's satisfaction with treatment
Description
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.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Kaczynski, DDS
Phone
+48 22 502 20 99
Email
t.kaczynski@me.com
Facility Information:
Facility Name
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
City
Warsaw
State/Province
Mazowsze
ZIP/Postal Code
00-246
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Batlomiej Gorski, DDS, PhD
Phone
+48 22 502 20 99

12. IPD Sharing Statement

Citations:
PubMed Identifier
34431001
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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