Stability of Root Coverage Outcomes After Soft‐Tissue Augmentation With a Collagen Matrix With or Without rhPDGF‐BB: A 3‐Year Triple‐Blinded, Randomised, Placebo‐Controlled Trial

IF 6.8 1区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Journal of Clinical Periodontology Pub Date : 2025-09-11 DOI:10.1111/jcpe.70030

Lorenzo Tavelli, Shayan Barootchi, Maria Vera Rodriguez, Leonardo Mancini, Hamoun Sabri, Tu Nguyen, Jad Majzoub, Suncica Travan, William V. Giannobile

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Abstract

AimTo evaluate the 3‐year stability of root coverage outcomes following treatment with a coronally advanced flap (CAF) and a volume‐stable, cross‐linked xenogeneic collagen matrix (VCMX), either soaked in recombinant human platelet–derived growth factor‐BB (rhPDGF, test arm) or sterile saline (control arm).MethodsOf the original 30 participants in the triple‐blind, randomised, placebo‐controlled trial, 26 were available for follow‐up at 1 and 3 years. The primary outcome was mean root coverage (mRC) at 3 years compared to the 6‐month results. Secondary outcomes included complete root coverage, keratinised tissue width, gingival thickness, volumetric and aesthetic changes, patient‐reported outcome measures (PROMs) and ultrasonographic tissue properties. Untreated contralateral teeth were also assessed.ResultsFrom 6 months to 3 years, mRC decreased by 6.7% in the control arm and 7.5% in the test arm (p > 0.05). Over 90% of treated sites maintained a stable gingival margin (≤ 0.5 mm shift). No significant inter‐group differences were found for volumetric, aesthetic or PROM outcomes. Ultrasonography revealed increased tissue elasticity in treated sites. In contrast, untreated contralateral sites showed progressive gingival recession and increased hypersensitivity (p < 0.001).ConclusionBoth VCMX treatments demonstrated stable clinical and ultrasonographic outcomes over 3 years, while untreated sites showed signs of soft‐tissue deterioration.

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有或没有rhPDGF - BB的胶原基质软组织增强后根覆盖结果的稳定性：一项为期3年的三盲、随机、安慰剂对照试验

目的评估冠状进展皮瓣（CAF）和体积稳定的交联异种胶原基质（VCMX）治疗后根部覆盖结果的3年稳定性，分别浸泡在重组人血小板衍生生长因子- BB （rhPDGF，测试组）或无菌生理盐水（对照组）中。方法在最初的30名三盲、随机、安慰剂对照试验的参与者中，有26人在1年和3年随访。主要结果是3年的平均根覆盖（mRC）与6个月的结果的比较。次要结果包括牙根完全覆盖、角化组织宽度、牙龈厚度、体积和美观变化、患者报告的结果测量（PROMs）和超声组织特性。对未治疗的对侧牙齿也进行了评估。结果6个月至3年，对照组mRC下降6.7%，试验组mRC下降7.5% （p > 0.05）。超过90%的治疗部位保持稳定的龈缘（≤0.5 mm移位）。在体积、美观或PROM结果方面，组间无显著差异。超声检查显示治疗部位组织弹性增加。相比之下，未经治疗的对侧部位显示进行性牙龈萎缩和增加的超敏反应（p < 0.001）。结论两种VCMX治疗在3年内均表现出稳定的临床和超声结果，而未治疗的部位出现软组织恶化迹象。

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来源期刊

Journal of Clinical Periodontology 医学-牙科与口腔外科

CiteScore

13.30

自引率

10.40%

发文量

175

审稿时长

3-8 weeks

期刊介绍： Journal of Clinical Periodontology was founded by the British, Dutch, French, German, Scandinavian, and Swiss Societies of Periodontology. The aim of the Journal of Clinical Periodontology is to provide the platform for exchange of scientific and clinical progress in the field of Periodontology and allied disciplines, and to do so at the highest possible level. The Journal also aims to facilitate the application of new scientific knowledge to the daily practice of the concerned disciplines and addresses both practicing clinicians and academics. The Journal is the official publication of the European Federation of Periodontology but wishes to retain its international scope. The Journal publishes original contributions of high scientific merit in the fields of periodontology and implant dentistry. Its scope encompasses the physiology and pathology of the periodontium, the tissue integration of dental implants, the biology and the modulation of periodontal and alveolar bone healing and regeneration, diagnosis, epidemiology, prevention and therapy of periodontal disease, the clinical aspects of tooth replacement with dental implants, and the comprehensive rehabilitation of the periodontal patient. Review articles by experts on new developments in basic and applied periodontal science and associated dental disciplines, advances in periodontal or implant techniques and procedures, and case reports which illustrate important new information are also welcome.