Evaluation of the Safety and Efficacy of Soft Tissue Augmentation with a Compressive-Resistant Collagen Matrix in a Non-Human Primate Model

Publication date: Available online 1 September 2018

Source: Journal of Oral and Maxillofacial Surgery

Author(s): Alan S. Herford, Katina Nguyen, Meagan Miller, Rahul Tandon, Fabrizio Signorino

Abstract

Purpose

The purpose of the present study was to evaluate the safety and efficacy of compression resistant collagen-based cross-linked matrix for augmentation of maxillary and mandibular soft tissue defects in an animal model.

Materials and Methods

Six Rhesus monkeys were subjected to soft tissue grafting in four sites intra-orally; the anterior maxilla was subjected to hard and soft tissue grafting with implant placement. Each site was randomly assigned one of three treatments: a compressive-resistant collagen membrane (CM), a subepithelial connective tissue autograft (SCTG), or sham, where a partial thickness flap was elevated then sutured closed and no further treatment was provided (control). The following methods were used for data collection: in vivo evaluation via periodontal probing, ultrasound, shear modulus elasticity, polyether impressions for volumetric analysis, and in vitro analysis via histological biopsies. In vitro analysis provided by histological measurements and evaluations were performed on non-decalcified sections. Follow-up period was six months.

Results

SCTG and CM demonstrated favorable tissue integration. No adverse reaction or deviation from normal healing processes was detected. CM integrated well in all sites with a variable range of soft tissue volume increase. Volumetric discrepancies were appreciated in the histological analyses and differences were found when CM and SCTG were applied in the anterior maxilla in combination with hard tissue grafting and implant placement. Histological evaluation demonstrated favorable integration, no immunogenic response to the CM, and stable volumetric retention in autograft and CM sites over the experimental period.

Conclusion

Compressive-resistant collagen matrix may be a safe and efficacious alternative for soft tissue augmentation, eliminating the need for a donor site and the consequent reduction of morbidity. While it was possible to observe similar performance between CM and SCTG, further studies will be necessary to estimate the clinical potentiality and describe the limits of the technique.

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