Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions
1 other identifier
interventional
28
1 country
1
Brief Summary
The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II. This study is a randomized-controlled clinical trial of 6 months duration.
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 Oct 2014
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 13, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedDecember 18, 2015
December 1, 2015
6 months
December 13, 2015
December 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical attachment level (CAL)
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
6 months
Secondary Outcomes (6)
Recession depth (RD)
6 months
Recession width (RW)
6 months
Width of keratinized tissue (KTW)
6 months
Recession area (RA)
6 months
the average percentage of root coverage (ARC)
6 months
- +1 more secondary outcomes
Other Outcomes (1)
The depth of gingival sulcus (PD)
6 months
Study Arms (2)
Control group
ACTIVE COMPARATORSurgery:The tunnel technique for covering gingival recession. Graft: connective tissue.
Study group
ACTIVE COMPARATORSurgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm).
Interventions
The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
Eligibility Criteria
You may qualify if:
- Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.
You may not qualify if:
- Approximal Plaque Index (API) \> 15%,
- Sulcus Bleeding Index (SBI) \> 10%,
- Systemic diseases with compromised healing potential or infectious diseases,
- Untreated periodontal conditions,
- Pregnant and lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontal and Oral Mucosa Diseases
Zabrze, 41-800, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marta Tanasiewicz, Professor
Department of Conservative Dentistry with Endodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD DDS
Study Record Dates
First Submitted
December 13, 2015
First Posted
December 16, 2015
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
December 18, 2015
Record last verified: 2015-12