Impact of Implant-supported Removable Prosthesis Versus Fixed Prosthesis on Quality of Life in Edentulous Patients: a Multicenter Non-inferiority Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Measurement of the evolution of the quality of life using the GOHAI questionnaire
研究概览
简要总结
Comparison between fixed and removable implant-retained complete prostheses previously showed that while patients appreciate the ergonomic cleaning of removable prostheses, they prefer the comfort and masticatory efficiency of fixed prostheses. New treatment strategies are emerging; the use of telescopic attachments now offers a prosthetic alternative for the treatment of edentulous teeth at a lower financial cost than fixed prostheses.
To answer this question, the study is constructed as a cross-over. 30 patients will use a removable telescopic prosthesis and then a fixed prosthesis, or vice versa, for a period of 6 months according to randomization. They will answer a quality of life questionnaire after each period and finally choose their favorite prosthesis. The null hypothesis is that removable telescopic implant prostheses will result in a quality of life comparable to that obtained with fixed implant-supported prostheses.
The primary objective of this study is to demonstrate the non-inferiority of removable versus fixed prostheses on quality of life after 6 months of use of each implant-supported prosthesis in edentulous maxillary or mandibular patients. The measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire after 6 months of use of each prosthesis.
The secondary objectives are to:
- Determine the decisional parameters in the final choice of the prosthesis by the patient at the end of the study, with the Mc Gill Denture Satisfaction Instrument,
- Compare the masticatory efficiency between the two dentures (duration, number of cycles and frequency of chewing of the carrot test food, with each denture after 6 months of use),
- Compare the oral hygiene between the two prostheses (peri-implant plaque index, after 6 months for each prosthesis),
- Compare the adjustments and repair required after the placement of each prosthesis and the chairside treatment time to achieve them,
- Compare the complications and their frequency of occurrence with each type of prosthesis during the 6-month wearing period.
详细描述
Edentulism is defined as the loss of all natural teeth and is an important public health issue globally for its high prevalence (exceeding 10% in adults aged ≥ 50 years) and associated disability Epidemiological studies show a decrease in the prevalence of total edentulism but an increase in the number of edentulous people in the world in general and in Western society in particular, linked to the increase in life expectancy. In Europe, the edentulism rate varies greatly from one country to another. According to the WHO, in the 65+ age group, the rate of total edentulism in 2000 was 60-70% in some European countries and still 15% in France.
Prosthetic rehabilitation is a factor of social inequalities in health insofar as this care is poorly covered or not covered by social organizations. The different treatment solutions must be examined in terms of the gain they represent in terms of quality of life compared to their cost.
The improvement of retention of a removable prosthesis with implants was demonstrated. The comparison between fixed and removable implant-retained prostheses previously showed that while patients appreciate the ergonomic cleaning of removable prostheses, they prefer the comfort and masticatory efficiency of fixed prostheses. New treatment strategies are emerging; the use of telescopic attachments now offers a prosthetic alternative for the treatment of edentulous teeth at a lower financial cost than fixed prostheses. This treatment option is not well known. There are no randomized controlled studies directly comparing these two therapies in terms of quality of life.
To answer this question, the study is constructed as a cross-over. 30 patients will use a removable telescopic prosthesis and then a fixed prosthesis, or vice versa, for a period of 6 months according to randomization. They will answer a quality of life questionnaire after each period and finally choose their favorite prosthesis. The null hypothesis is that removable telescopic implant prostheses will result in a quality of life comparable to that obtained with fixed implant-supported prostheses.
The primary objective of this study is to demonstrate the non-inferiority of removable versus fixed prostheses on quality of life after 6 months of use of each implant-supported prosthesis in edentulous maxillary or mandibular patients. The measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire after 6 months of use of each prosthesis, i.e. twice during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- •Patients ≥ 18 years of age;
- •Mandibular AND/OR maxillary edentulous patients, treated with satisfying conventional denture for a minimum of 3 months;
- •Bone volume compatible with the placement of implants of at least 9 mm in length;
- •Sufficient inter-arch space;
- •Free and informed consent;
- •Affiliated to the social security fund.
排除标准
- •Systemic pathologies contraindicating the placement of implants (unbalanced diabetes, biphosphonates);
- •Smoking patient > 10 cigarettes per day;
- •Class IV bone according to the Leckholm and Zarb classification.
研究组 & 干预措施
Patients treated with fixed implant denture
Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Fixed denture is considered the standard protocol.
干预措施: fixed implant denture (Other)
Patients treated with fixed implant denture
Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Fixed denture is considered the standard protocol.
干预措施: removable implant denture (Other)
Patients treated with removable implant denture
Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Removable denture is considered the experimental protocol.
干预措施: fixed implant denture (Other)
Patients treated with removable implant denture
Patients quality of life will be compared when using a removable implant denture and a fixed implant denture, in a cross-over design. Removable denture is considered the experimental protocol.
干预措施: removable implant denture (Other)
结局指标
主要结局
Measurement of the evolution of the quality of life using the GOHAI questionnaire
时间窗: 6 months
Measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire
次要结局
- Measurement of the duration of chewing of the carrot test food(6 months)
- Scores of the Mc Gill Denture Satisfaction Instrument(21 months)
- Measurement of the number of cycles of chewing of the carrot test food(6 months)
- Measurement of the frequency of chewing of the carrot test food(6 months)
- Peri-implant plaque index(6 months)
- Adjustments required after placement(6 months)
- Complications(6 months)