Jayaraman Srinivasan, Singh Balendra P, Ramanathan Balasubramanian, Pazhaniappan Pillai Murukan, MacDonald Laura, Kirubakaran Richard
Department of Prosthodontics, Faculty of Dentistry, Al Baha University, Al Baha, Saudi Arabia.
Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD012256. doi: 10.1002/14651858.CD012256.pub2.
Edentulism is relatively common and is often treated with the provision of complete or partial removable dentures. Clinicians make final impressions of complete dentures (CD) and removable partial dentures (RPD) using different techniques and materials. Applying the correct impression technique and material, based on an individual's oral condition, improves the quality of the prosthesis, which may improve quality of life.
To assess the effects of different final-impression techniques and materials used to make complete dentures, for retention, stability, comfort, and quality of life in completely edentulous people.To assess the effects of different final-impression techniques and materials used to make removable partial dentures, for stability, comfort, overextension, and quality of life in partially edentulous people.
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 November 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Register of Studies, to 22 November 2017), MEDLINE Ovid (1946 to 22 November 2017), and Embase Ovid (21 December 2015 to 22 November 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on language or publication status when searching the electronic databases, however the search of Embase was restricted by date due to the Cochrane Centralised Search Project to identify all clinical trials and add them to CENTRAL.
We included randomised controlled trials (RCTs) comparing different final-impression techniques and materials for treating people with complete dentures (CD) and removable partial dentures (RPD). For CD, we included trials that compared different materials or different techniques or both. In RPD for tooth-supported conditions, we included trials comparing the same material and different techniques, or different materials and the same technique. In tooth- and tissue-supported RPD, we included trials comparing the same material and different dual-impression techniques, and different materials with different dual-impression techniques.
Two review authors independently, and in duplicate, screened studies for eligibility, extracted data, and assessed the risk of bias for each included trial. We expressed results as risk ratios (RR) for dichotomous outcomes, and as mean differences (MD) or standardised mean differences (SMD) for continuous outcomes, with 95% confidence intervals (CI), using the random-effects model. We constructed 'Summary of findings' tables for the main comparisons and outcomes (participant-reported oral health-related quality of life, quality of the denture, and denture border adjustments).
We included nine studies in this review. Eight studies involved 485 participants with CD. We assessed six of the studies to be at high risk of bias, and two to be at low risk of bias. We judged one study on RPD with 72 randomised participants to be at high risk of bias.Overall, the quality of the evidence for each comparison and outcome was either low or very low, therefore, results should be interpreted with caution, as future research is likely to change the findings.Complete denturesTwo studies compared the same material and different techniques (one study contributed data to a secondary outcome only); two studies compared the same technique and different materials; and four studies compared different materials and techniques.One study (10 participants) evaluated two stage-two step, Biofunctional Prosthetic system (BPS) using additional silicone elastomer compared to conventional methods, and found no evidence of a clear difference for oral health-related quality of life, or quality of the dentures (denture satisfaction). The study reported that BPS required fewer adjustments. We assessed the quality of the evidence as very low.One study (27 participants) compared selective pressure final-impression technique using wax versus polysulfide elastomeric (rubber) material. The study did not measure quality of life or dentures, and found no evidence of a clear difference between interventions in the need for adjustments (RR 0.81, 95% CI 0.38 to 1.70). We assessed the quality of the evidence as very low.One study compared two stage-two step final impression with alginate versus silicone elastomer. Oral health-related quality of life measured by the OHIP-EDENT seemed to be better with silicone (MD 7.20, 95% CI 2.71 to 11.69; 144 participants). The study found no clear differences in participant-reported quality of the denture (comfort) after a two-week 'confirmation' period, but reported that silicone was better for stability and chewing efficiency. We assessed the quality of the evidence as low.Three studies compared single-stage impressions with alginate versus two stage-two step with elastomer (silicone, polysulfide, or polyether) impressions. There was no evidence of a clear difference in the OHIP-EDENT at one month (MD 0.05, 95% CI -2.37 to 2.47; two studies, 98 participants). There was no evidence of a clear difference in participant-rated general satisfaction with dentures at six months (MD 0.00, 95% CI -8.23 to 8.23; one study, 105 participants). We assessed the quality of the evidence as very low.One study compared single-stage alginate versus two stage-two step using zinc-oxide eugenol, and found no evidence of a clear difference in OHIP-EDENT (MD 0.50, 95% CI -2.67 to 3.67; 39 participants), or general satisfaction (RR 3.15, 95% CI 0.14 to 72.88; 39 participants) at six months. We assessed the quality of the evidence as very low.Removable partial denturesOne study randomised 72 participants and compared altered-cast technique versus one-piece cast technique. The study did not measure quality of life, but reported that most participants were satisfied with the dentures and there was no evidence of any clear difference between groups for general satisfaction at one-year follow-up (low-quality evidence). There was no evidence of a clear difference in number of intaglio adjustments at one year (RR 1.43, 95% CI 0.61 to 3.34) (very low-quality evidence).
AUTHORS' CONCLUSIONS: We conclude that there is no clear evidence that one technique or material has a substantial advantage over another for making complete dentures and removable partial dentures. Available evidence for the relative benefits of different denture fabrication techniques and final-impression materials is limited and is of low or very low quality. More high-quality RCTs are required.
无牙颌相对常见,通常采用全口或局部可摘义齿进行治疗。临床医生使用不同的技术和材料对全口义齿(CD)和可摘局部义齿(RPD)进行终印模制取。根据个体口腔状况应用正确的印模技术和材料,可提高修复体质量,进而可能改善生活质量。
评估用于制作全口义齿的不同终印模技术和材料对无牙颌患者的固位、稳定性、舒适度和生活质量的影响。评估用于制作可摘局部义齿的不同终印模技术和材料对部分牙列缺损患者的稳定性、舒适度、伸展过度情况和生活质量的影响。
Cochrane口腔健康信息专家检索了以下数据库:Cochrane口腔健康试验注册库(截至2017年11月22日)、Cochrane对照试验中央注册库(CENTRAL)(Cochrane研究注册库,截至2017年11月22日)、MEDLINE Ovid(1946年至2017年11月22日)和Embase Ovid(2015年12月21日至2017年11月22日)。检索了美国国立卫生研究院试验注册库(ClinicalTrials.gov)和世界卫生组织国际临床试验注册平台以查找正在进行的试验。在检索电子数据库时未对语言或发表状态设限,然而由于Cochrane集中检索项目旨在识别所有临床试验并将其添加到CENTRAL,所以Embase的检索受日期限制。
我们纳入了比较用于治疗全口义齿(CD)和可摘局部义齿(RPD)患者的不同终印模技术和材料的随机对照试验(RCT)。对于全口义齿,我们纳入了比较不同材料或不同技术或两者的试验。对于牙支持式可摘局部义齿,我们纳入了比较相同材料和不同技术,或不同材料和相同技术的试验。对于牙和组织支持式可摘局部义齿,我们纳入了比较相同材料和不同双重印模技术,以及不同材料和不同双重印模技术的试验。
两位综述作者独立且重复地筛选研究的纳入资格、提取数据,并评估每个纳入试验的偏倚风险。我们将结果表示为二分类结局的风险比(RR),以及连续结局的均值差(MD)或标准化均值差(SMD),并采用随机效应模型计算95%置信区间(CI)。我们为主要比较和结局(参与者报告的口腔健康相关生活质量、义齿质量和义齿边缘调整)构建了“结果总结”表。
我们在本综述中纳入了9项研究。8项研究涉及485名全口义齿患者。我们评估其中6项研究存在高偏倚风险,2项研究存在低偏倚风险。我们判定一项涉及72名随机参与者的可摘局部义齿研究存在高偏倚风险。总体而言,每个比较和结局的证据质量均为低或极低,因此,结果应谨慎解读,因为未来的研究可能会改变这些发现。全口义齿两项研究比较了相同材料和不同技术(一项研究仅为次要结局贡献了数据);两项研究比较了相同技术和不同材料;四项研究比较了不同材料和技术。一项研究(10名参与者)评估了使用额外硅橡胶的两阶段生物功能性修复系统(BPS)与传统方法相比,未发现口腔健康相关生活质量或义齿质量(义齿满意度)有明显差异的证据。该研究报告称BPS所需调整较少。我们评估该证据质量为极低。一项研究(27名参与者)比较了使用蜡与聚硫橡胶弹性体(橡胶)材料的选择性压力终印模技术。该研究未测量生活质量或义齿情况,未发现干预措施在调整需求方面有明显差异的证据(RR 0.81,95%CI 0.38至1.70)。我们评估该证据质量为极低。一项研究比较了藻酸盐与硅橡胶弹性体的两阶段终印模。用OHIP - EDENT测量的口腔健康相关生活质量似乎硅橡胶更好(MD 7.20,95%CI 2.71至11.69;144名参与者)。该研究发现在两周的“确认”期后,参与者报告的义齿质量(舒适度)无明显差异,但报告称硅橡胶在稳定性和咀嚼效率方面更好。我们评估该证据质量为低。三项研究比较了藻酸盐单阶段印模与弹性体(硅橡胶、聚硫橡胶或聚醚)两阶段印模技术六个月时的OHIP - EDENT情况,未发现明显差异的证据(MD 0.05,95%CI - 2.37至2.47;两项研究,98名参与者)。一项研究(105名参与者)六个月时参与者对义齿的总体满意度未发现明显差异的证据(MD 0.00,95%CI - 8.23至8.23)。我们评估该证据质量为极低。一项研究比较了藻酸盐单阶段印模与使用氧化锌丁香酚的两阶段印模技术六个月时的OHIP - EDENT情况,未发现明显差异的证据(MD 0.50,95%CI - 2.67至3.67;39名参与者),或总体满意度(RR 3.15,95%CI 0.14至72.88;39名参与者)。我们评估该证据质量为极低。可摘局部义齿一项研究将72名参与者随机分组,比较了改良铸型技术与整体铸造技术。该研究未测量生活质量,但报告称大多数参与者对义齿满意,在一年随访时两组在总体满意度方面未发现明显差异的证据(低质量证据)。一年时内凹调整次数未发现明显差异的证据(RR 1.43,95%CI 0.61至3.34)(极低质量证据)。
我们得出结论,没有明确证据表明一种技术或材料在制作全口义齿和可摘局部义齿方面比另一种具有实质性优势。关于不同义齿制作技术和终印模材料相对益处的现有证据有限,且质量低或极低。需要更多高质量的随机对照试验。