Clinical Survival of Indirect, Lateral-posterior 3-unit Occlusal-retained Fiber-reinforced Composite Fixed Dental Prosthesis: 15-years Follow-up
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
- 是
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
Nicola Barabanti
DMD
BNM Clinic and Research
