NCT03580811

Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants

The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.

Detailed description

Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.

Conditions

• Dental Implants

Interventions

Type	Name	Description
DEVICE	Dental Implant &ADMG	A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .
DEVICE	Dental implant & ADMG & BDX	Dental Implant will be placed with ADMG that covers the BDX

Timeline

• Start date: 2018-12-04
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2018-07-09
• Last updated: 2021-06-03

Locations

1 site across 1 country: United States