NCT03582995

Brief Summary

The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 13, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

June 13, 2018

Last Update Submit

June 2, 2021

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (1)

  • Percentage of root coverage

    Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100

    4 months

Secondary Outcomes (1)

  • Tissue thickness

    4 months

Study Arms (2)

Flap Surgery for root coverage with Alloderm and xenograft

ACTIVE COMPARATOR

Root coverage surgery using a flap technique

Procedure: Flap Surgery for root coverage with Alloderm and xenograft

Tunnel Surgery for root coverage with Alloderm and xenograft

EXPERIMENTAL

Root coverage surgery using a tunnel technique

Procedure: Tunnel Surgery for root coverage with Alloderm and xenograft

Interventions

Flap Surgery for root coverage with Alloderm and xenograftPROCEDURE

A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage

Flap Surgery for root coverage with Alloderm and xenograft
Tunnel Surgery for root coverage with Alloderm and xenograftPROCEDURE

A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.

Tunnel Surgery for root coverage with Alloderm and xenograft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
  • B. The mucogingival defect must be on a non-molar tooth.
  • C. Patients must be ≥ 18 years of age.

You may not qualify if:

  • A. Patients with debilitating systemic or diseases that significantly affect the periodontium.
  • B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
  • C. Patients requiring antibiotic prophylaxis.
  • D. Root surface restorations at the site of recession.
  • E. No detectable CEJ
  • F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
  • G. Patients who are pregnant or lactating.
  • H. Patients who use tobacco products (smoking or smokeless tobacco).
  • I. Patients with alcohol abuse problems.
  • J. Patients undergoing long-term steroid therapy.
  • K. History of previous root coverage procedures, graft or GTR, on the test teeth.
  • L. Patients who fail to complete the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

AllodermTransplantation, Heterologous

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Henry Greenwell, DMD, MS

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 11, 2018

Study Start

October 23, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)