The Clinical Effect of Implant Placement With a Simultaneous Soft Tissue Allograft
1 other identifier
interventional
28
1 country
1
Brief Summary
Dental implant placement and simultaneous grafting using one layer gum graft will result in the same facial ridge contour and soft tissue thickness as one layer of gum graft plus bone graft.
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 Jul 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
First Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 8, 2016
May 1, 2014
10 months
April 25, 2014
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Buccal soft tissue contour around dental implant.
Contour will be categorized as concave, flat, or convex (subjective categories).
4 months post dental implant placement.
Secondary Outcomes (2)
Buccal soft tissue thickness around dental implant.
4 months post dental implant placement.
Buccal soft tissue healing around dental implant.
4 months post dental implant placement.
Study Arms (2)
Dental Implant & ADM
ACTIVE COMPARATORDental implant placement plus simultaneous grafting use one layer of ADM.
Dental Implant & ADM & bone xenograft
EXPERIMENTALDental implant placement plus simultaneous grafting use one layer of ADM with bovine xenograft.
Interventions
A dental implant will be placed and the buccal soft tissue will be grafted using an acellular dermal matrix allograft.
A dental implant will be placed along with a buccal acellular dermal matrix allograft which will cover a bone xenograft.
Eligibility Criteria
You may qualify if:
- Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADM with or without bovine-derived xenograft.
- Healthy persons at least 18 years old.
- Understands and has signed the informed consent.
You may not qualify if:
- Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
- Previous head and neck radiation.
- Patients who have taken oral bisphosphonates for \> 3 years or any IV bisphosphonates.
- Smokers (or other tobacco habits that might interfere with soft tissue healing).
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
- Chemotherapy in the previous 12 months.
- Psychological problems that would interfere with treatment.
- Patients unable or unwilling to sign the informed consent.
- Pregnant subjects will be excluded due to risk of miscarriage.
- Failure of patient to follow treatment protocol.
- Failure of implant to osseointegrate.
- Failure of the allograft to heal.
- Unanticipated healing complications that will adversely affect treatment results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Graduate Periodontics, University of Louisville School of Dentistry
Louisville, Kentucky, 40292, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ting-wei H Hsu, D.M.D
Co-investigator, University of Louisville
- PRINCIPAL INVESTIGATOR
Henry Greenwell, D.M.D, M.S.D
University of Louisville
- STUDY DIRECTOR
Bobby L Cockerham, DDS
Co-investigator University of Louisville
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
- DMD, MSD
Study Record Dates
First Submitted
April 25, 2014
First Posted
May 15, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 8, 2016
Record last verified: 2014-05