Camelo Marcelo, Nevins Marc L, Schenk Robert K, Lynch Samuel E, Nevins Myron
Harvard School of Dental Medicine, Boston, USA.
Int J Periodontics Restorative Dent. 2003 Jun;23(3):213-25.
This human clinical trial evaluated the clinical and histologic response to recombinant human platelet-derived growth factor-BB (rhPDGF-BB) delivered in bone allograft for the treatment of advanced Class II furcation defects. Three mandibular and one maxillary molar furcation defects were treated: Two received 0.5 mg/mL and two received 1.0 mg/mL rhPDGF-BB, in all cases mixed with DFDBA. Clinical probing depths and attachment levels were obtained presurgically and 9 months postsurgical, after which the teeth and surrounding tissues were removed en bloc. Both concentrations of rhPDGF-BB resulted in substantially improved horizontal (mean 3.5 mm) and vertical (mean 4.25 mm) probing depths and attachment levels (mean 3.75 mm). Histologic evaluation revealed periodontal regeneration, including new bone, cementum, and periodontal ligament coronal to the reference notch. Regeneration was also present coronal to the original osseous crest In one case where an enamel projection extended into the fornix of the furcation, new calcified tissue with new inserting connective tissue fibers was observed over the enamel. This study documented the favorable tissue response to rhPDGF-BB treatment at both the clinical and microscopic levels, provided the first human histologic evidence that new calcified tissue with inserting collagen fibers can occur over enamel projections within furcations, and demonstrated for the first time that complete periodontal regeneration can be achieved in advanced Class II furcation defects using a combination of purified recombinant growth factor and bone allograft.
这项人体临床试验评估了异体骨移植中递送的重组人血小板衍生生长因子-BB(rhPDGF-BB)治疗晚期II类根分叉病变的临床和组织学反应。治疗了3个下颌磨牙和1个上颌磨牙的根分叉病变:2例接受0.5mg/mL,2例接受1.0mg/mL rhPDGF-BB,所有病例均与脱矿冻干骨(DFDBA)混合。在手术前和手术后9个月测量临床探诊深度和附着水平,之后将牙齿及周围组织整块切除。两种浓度的rhPDGF-BB均使水平探诊深度(平均3.5mm)和垂直探诊深度(平均4.25mm)以及附着水平(平均3.75mm)得到显著改善。组织学评估显示牙周组织再生,包括在参考切口冠方出现新骨、牙骨质和牙周膜。在原牙槽嵴冠方也有再生。在1例釉质突起延伸至根分叉穹窿部的病例中,在釉质上方观察到有新插入结缔组织纤维的新钙化组织。本研究记录了rhPDGF-BB治疗在临床和微观层面均产生了良好的组织反应,提供了首个关于在根分叉内釉质突起上方可出现带有插入胶原纤维的新钙化组织的人体组织学证据,并首次证明使用纯化的重组生长因子与异体骨移植联合应用可在晚期II类根分叉病变中实现完全的牙周组织再生。