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临床试验/NCT02764463
NCT02764463Unknown不适用

Clinical Survival of Indirect, Lateral-posterior 3-unit Occlusal-retained Fiber-reinforced Composite Fixed Dental Prosthesis: 15-years Follow-up

BNM Clinic and Research0 个研究点目标入组 58 人开始时间: 1999年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
58
主要终点
Debonding of restoration

研究概览

简要总结

This prospective clinical study evaluated the performance of indirect, posterior occlusal-retained, fiber-reinforced-composite restorations.

Methods: Between June 1999 and June 2000, a total of 58 patients aged between 33 and 62 years old ( 33 male, 25 female) received 65 FCRFPD prosthesis.

All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer) and cemented according to the instructions of resin cement Variolink II (Ivoclar Vivadent). After baseline recordings, patients were followed at 6 months and thereafter annually up to 15 years. The evaluation protocol involved technical (chipping, debonding or fracture of tooth/restoration) and biological failures (caries).

详细描述

As of January 1999, FRC FDPs are offered as alternative to other conventional therapy options at the Department where the study was conducted. Between June-1999 and June-2000, 58 patients aged between 33 and 62 years old (25 females, 33 males, mean age: 47) received 65 indirect posterior FRC FDPs. Before enrolment in the trial, all patients were provided with a written informed consent Information was given to each patient regarding the alternative treatment options. The inclusion criteria were as follows: all subjects were required to be at least 18 years old, able to read and sign the informed consent document, physically and psychologically able to tolerate conventional restorative procedures, having no active periodontal or pulpal diseases, having no primary caries, not allergic to resin-based materials, not pregnant or nursing, having antagonist teeth opposing the FRC FDP to be restored, willing to return for follow-up examinations as outlined by the investigators. The patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.

All the restorations were performed by a single operator, selected considering his clinical experience (>10 years since graduation).

All FDPs replaced one missing tooth and bonded to two adjacent abutment teeth were used for retention. No cantilever FDPs were involved.

Treatment was performed in two sessions: 1) Teeth preparation and Impression taking and model analysis, 2) Try-in, cementation and polishing of the FDP.

In the first session, after an accurate evaluation of spaces and residual dental tissues and the acceptance of this type of treatment by the patient, pillar teeth were prepared using diamond bur on high speed handpiece with mesio-occlusal, disto-occlusal, MOD, onlay or overlay preparations according to each clinical situation. Cavity preparation is required not only to remove all carious tissue, but to create a minimal space necessary to the glass fibers to support occlusal loads. According to "Munack" a cavity with 2x2mm occlusal surface and 2mm depth is able to support a 600N masticatory stress before breaking, and by increasing depth to 4mm we can reach 700N.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All subjects were required to be at least 18 years old, able to read and sign the informed consent document
  • Physically and psychologically able to tolerate conventional restorative procedures
  • Having no active periodontal or pulpal diseases
  • Having no primary caries
  • Not allergic to resin-based materials
  • Not pregnant or nursing
  • Having antagonist teeth opposing the FRC FDP to be restored
  • Willing to return for follow-up examinations as outlined by the investigators.

排除标准

  • Patients who had more absent teeth than the tooth to be replaced in the rest of the dentition or those having diastemas were not excluded.

结局指标

主要结局

Debonding of restoration

时间窗: 15 Years

According to USPHS criteria

Fracture of Tooth

时间窗: 15 Years

According to USPHS criteria

Fracture of Restorations

时间窗: 15 Years

According to USPHS criteria

Chipping of restoration

时间窗: 15 Years

According to USPHS criteria

次要结局

  • Secondary caries of the tooth(15 Years)

研究者

发起方
BNM Clinic and Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Barabanti

DMD

BNM Clinic and Research

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