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临床试验/NCT02894528
NCT02894528已完成4 期

Evaluation of a Synthetic Bone Substitute Associated With Absorbable Collagen Membrane for Ridge Preservation After Tooth Extraction. Clinical and Tomographic Randomized Study in Humans.

University of Sao Paulo0 个研究点目标入组 15 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
15
主要终点
Change the dimensions presented by the alveolar ridge after comparison of measurements at baseline and 180 days

研究概览

简要总结

Fifteen patients were selected, each presenting at least two jaw front teeth indicated for extraction: in the Test Group (TG), post-extraction sockets was filled by synthetic bone substitute ReproBone, and in the Control Group (CG) the socket was filled only by clot. In both groups, the sockets were covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap. Computed tomography scans were acquired in the immediate postoperative period and 6 months after surgery, and the horizontal and vertical dimensional changes in bone crests were quantified.

详细描述

Pre-surgical procedures Before surgical procedures, all patient received oral hygiene instructions, as well as supra and subgingival root planing procedures, in order to control periodontal infections and acute inflammatory processes that could interfere with the wound healing of the sockets. Surgical procedures were performed only after the plaque index reached levels below 20%.

Surgical procedures The patients received local anesthesia (mepivacaine hydrochloride 20 mg / ml epinephrine + 0.01 mg / ml), and afther that the teeth were carefully extracted using a periotome (Hu-friedy instruments, Chicago, IL, USA). Then, vertical releasing incisions were performed in the distal faces teeths adjacent to the socket with a 15C scalpel blade, and connected by intrasulcular incisions (Figure 1b). After that, a full thickness flap was raised (Figure 1c). Granulation tissue was removed, and then clinical measurements in both selected sockets were made: Clinical Buccal Alveolar Measure (CBAM) - distance between the bottom of the socket and the buccal bone crest (Figure 1d); Clinical Palatal Alveolar Measure (CPAM) - distance between the bottom of the socket and the palatal bone crest; and Clinical Horizontal Alveolar Measure (CHAM) - distance between the buccal and palatal bone crests (Figure 1e).

Following that, in the Control Group (CG) the alveolus was filled with blood clot, while in the Test Group (TG) the alveolus was filled with a bone substitute ReproBone (Ceramisys Ltd., Sheffield,UK), (Fig. 1f). The choose between control and test sockets was randomized by a computer program (SPSS Inc., Chicago, IL, USA). The allocation of each treatment was stored in opaque envelope until immediately before the socket filling procedure.

After that, in both groups, the sockets were covered with a resorbable collagen membrane (BioMend, Zimmer Dental Inc., Carlsbad, CA, USA), which was fixed to the buccal bone plate with a titanium tack (2 mm apically to the socket bottom), which also served as a reference for tomographic measurements (Figure 1g). Then, the membrane was sutured to the lingual flap with 5-0 absorbable suture (B.Braun, Aesculap, Tuttilingen, Germany), and the flap was coronally positioned in order to cover completely the membrane (when necessary, the basis of the flap was carefully dissected to release the flap), and sutured with 4-0 silk sutures (Ethicon, Johnson & Johnson, São Paulo, Brazil), (Figure 1h). All the surgical procedures were performed by the same experimented surgeon.

Post surgical procedures All patients received systemic antibiotics (amoxycillin 500 mg, 3x day) starting 24 hours before the surgical procedure and extending for 10 days after surgery. A non-steroidal antiinflammatory drug (Nimesulide 100mg) was also prescribed, twice a day, for 5 days, as well as analgesic (750 mg paracetamol of 8/8 hours, for 3 days). A 0.12% chlorhexidine digluconate solution was prescribed as mouth rinse to be used twice a day for fifteen days. The patients were instructed to discontinue tooth brushing in the surgical area during this period. Ten days after surgery, silk sutures were removed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 20 teeth
  • Minimum of two upper front teeth with indication for extraction after clinical and radiographic examinations.

排除标准

  • Subjects were excluded if they had systemic involvement that can interfere with periodontal treatment (e.g.: osteoporosis, diabetes, hypertension decompensated heart disease)
  • Prolonged use of anti-inflammatory or steroids
  • Known allergy to any biomaterial used in the study
  • Or who were pregnant/lactating or developed this systemic condition throughout the study.

研究组 & 干预措施

Ridge Preservation (Test Group)

Experimental

干预措施: BioMend and ReproBone (Drug)

Ridge Preservation (Control Group)

Active Comparator

干预措施: BioMend without ReproBone (Drug)

结局指标

主要结局

Change the dimensions presented by the alveolar ridge after comparison of measurements at baseline and 180 days

时间窗: The tomographic parameters, in millimeters, were recorded at baseline (transurgical) and 180 days after surgical procedure

Tomographic Analysis were performed for to check the efficacy of ReproBone associated to Biomend in the preservation of the socket. The following parameters were checked: Tomographic Buccal Alveolar Measure (TBAM), distance between the tack and buccal alveolar crest; Tomographic Palatal Alveolar Measure (TPAM), distance between the tack and palatal bone crest; Tomographic Horizontal Apical Measure (THAM), distance between buccal and palatal bone plates, at tack level; Tomographic Horizontal Cervical Measure (THCM), distance between buccal and palatal bone plates, at crestal level; Tomographic Alveolar Height Measure (TAHM), distance between a line defined by the buccal and palatal bone crests and the THAM line.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Luis Scombatti de Souza

Dr.

University of Sao Paulo

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