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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2019
CompletedJanuary 24, 2018
January 1, 2018
12 months
November 8, 2017
January 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment level (CAL)
Distance from the cementoenamel junction to the bottom of the gingival sulcus
6 months after surgery
Secondary Outcomes (6)
Recession height (RH)
6 months after surgery
Recession width (RW)
6 months after surgery
Width of keratinized tissue (WKT)
6 months after surgery
Thickness of keratinized tissue (TKT)
6 months after surgery
Average recession coverage (ARC)
6 months after surgery
- +1 more secondary outcomes
Other Outcomes (4)
Probing pocket depth (PPD)
6 months after surgery
Root coverage esthetic score (RES)
6 months after surgery
Post surgical pain and swelling
1, 2, 4, 7 and 14 days after surgery
- +1 more other outcomes
Study Arms (2)
Recession coverage with connective tissue graft + Emdogain®
EXPERIMENTALA 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.
Recession coverage with connective tissue graft
ACTIVE COMPARATORProcedure: 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.
Interventions
The tunnel technique for root coverage with Emdogain
The tunnel technique for root coverage without Emdogain
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, 00-246, Poland
Related Publications (1)
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.
PMID: 34431001DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2017
First Posted
November 27, 2017
Study Start
January 22, 2018
Primary Completion
January 5, 2019
Study Completion
May 5, 2019
Last Updated
January 24, 2018
Record last verified: 2018-01