Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial

IF 4.2 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE
Donald S. Clem, Pamela K. McClain, Michael K. McGuire, Chris R. Richardson, Greg A. Santarelli, Rachel A. Schallhorn, E. Todd Scheyer, John C. Gunsolley, Thiago Morelli
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引用次数: 0

Abstract

Background

Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants.

Methods

Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO).

Results

There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX “grafts” were by design larger than CTG, and surgery time was less (27% less, p = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (p < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies.

Conclusions

Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies—site sensitivity and esthetics improved similarly for both therapies—but surgery time and pain following surgery were significantly less for VCMX.

用于现有种植体周围软组织体积增大的收获移植替代物:随机、对照和盲法多中心试验
通过一项单盲、随机、对照、多中心、基于实践的临床试验,比较了体积稳定胶原基质(VCMX)和结缔组织移植(CTG)在现有牙科种植体周围软组织增量方面的效果。
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来源期刊
Journal of periodontology
Journal of periodontology 医学-牙科与口腔外科
CiteScore
9.10
自引率
7.00%
发文量
290
审稿时长
3-8 weeks
期刊介绍: The Journal of Periodontology publishes articles relevant to the science and practice of periodontics and related areas.
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