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

Phase 4

Completed

Interventions: Drug: Acellular Dermal Matrix
Procedure: Autologous subepithelial connective tissue graft

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Experimental	Acellular Dermal Matrix	Acellular Dermal Matrix
Control	Autologous subepithelial connective tissue graft	Autologous subepithelial connective tissue graft

Primary Outcome Measures

Name	Time	Method
Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery	Baseline and 16 weeks after baseline	Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points

Secondary Outcome Measures

Name	Time	Method
Patient-perceived Discomfort, Measured by VAS	2 weeks	Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded
Wound Healing, Measured Using a Standardized Visual Wound Healing Index	2 weeks	Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing
Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery	Baseline to 16 weeks after baseline

Locations (1): University of Iowa College of Dentistry - Craniofacial Clinical Research Center and Department of Periodontics
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Iowa City, Iowa, United States