NCT02450383

Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

Comparison of Two Different Surgical Approaches to Increase Peri-Implant Mucosa Thickness: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this non-inferiority trial is to determine the clinical efficacy of acellular dermal matrix (ADM) in the augmentation of the gum around dental implants as compared to an autologous gum graft (sCTG) obtained from the palate (roof of the mouth) in human adults. AlloDerm is regulated by the US Food and Drug Administration (FDA) as human tissue for transplantation. AlloDerm is processed and marketed in accordance with the FDA's requirements for banked human tissue (21 CFR, Part 1270 and Part 1271) and Standards for Tissue Banking of the American Association of Tissue Banks (AATB). Twenty adult subjects will be recruited who are in need of dental implant placement with simultaneous gum grafting to increase the thickness of the facial mucosa. Half of the subjects will be randomized to the ADM group and half will be randomized to the sCTG group. The surgical intervention will be performed according to the protocol and subjects will return for follow-up 2, 4, 8, and 16 weeks post-surgery for follow-up measurements of healing, gum thickness, subject perception of pain, and esthetic photographs.

Detailed description

Although little is known about the influence of peri-implant mucosa thickness (PMT) on long-term biologic outcomes, soft tissue thickness is a critical component to esthetic dental implant restorations. While the subepithelial connective tissue graft (sCTG) has been recognized as the gold standard for gingival augmentation, several studies have reported acellular dermal matrix (ADM) may produce similar outcomes. Healthy patients with a thin biotype were selected on the basis of an eligibility criteria and randomized to the control (sCTG) or test (ADM) group. Measurements were completed by a masked examiner at baseline and at implant uncovering. Patient reported outcomes were recorded, as well. A power analysis suggested 20 subjects be recruited. The gain in PMT at 1mm, 3mm and 5mm from the expected CEJ and recipient site wound dehiscence were measured and recorded in both groups at different time points by a calibrated, masked examiner. Patient-related outcome measures (PROMs), such as pain and level of satisfaction with final outcome, were also recorded for all study participants.

Conditions

• Tooth Loss
• Peri-implant Mucosa Defect

Interventions

Type	Name	Description
DRUG	Acellular Dermal Matrix	Placement of acellular dermal matrix (Alloderm®) on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach
PROCEDURE	Autologous subepithelial connective tissue graft	Placement of autologous subepithelial connective tissue graft on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-05-21
• Last updated: 2017-10-18
• Results posted: 2017-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study