School of Dentistry, Federal University of Goias, Avenida Universitária esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-020, Brazil.
Faculty of Dentistry, McGill University, 2001 McGill College Avenue, suite 500 Montreal, QC, H3A 1G1, Canada.
J Dent. 2018 Oct;77:43-50. doi: 10.1016/j.jdent.2018.07.006. Epub 2018 Jul 10.
This randomized clinical trial (RCT) aimed to assess the 1-year effectiveness of single-implant mandibular overdentures (SIMO) compared to conventional complete dentures (CCD).
In the first phase of the study, participants received new maxillary and mandibular CCDs. Then, they were randomly allocated to one of the study groups (CCD or SIMO). Participants in SIMO group received an external hexagon implant in the mandibular midline, with the immediate connection of an O-Ring/ball attachment. Oral health-related quality of life (OHIP-EDENT) and patient satisfaction in both groups were assessed before allocation and at 6- and 12-month follow-up visits. Both intention-to-treat (ITT) and per-protocol approaches were used for analyses. Statistical analyses were performed using the Wilcoxon Signed Ranks test and the Generalized Estimating Equations.
Eighty-four participants (CCD n = 42; SIMO n = 42) were included, out of which 70 completed the 12-month follow-up (CCD n = 34; SIMO n = 36). ITT analysis showed no changes for the CCD group in the longitudinal assessment compared to baseline. Participants in SIMO group had a significant improvement in OHIP-EDENT scores and satisfaction with the mandibular denture. No changes for the maxillary denture were observed in either groups. Similar results were found when per-protocol analysis was performed.
SIMO treatment resulted in a significant improvement in patient perceived outcomes compared to the CCD. SIMO may be considered as an alternative treatment modality for patients with poorly adapted and/or unstable mandibular dentures (ClinicalTrials.gov NCT03463174).
The immediately loaded single-implant mandibular overdenture markedly improved patient satisfaction and oral health-related quality of life of conventional denture wearers after a 12-month follow-up.
本随机临床试验（RCT）旨在评估单种植体下颌覆盖义齿（SIMO）与传统全口义齿（CCD）相比的 1 年有效性。
在研究的第一阶段，参与者接受了新的上颌和下颌 CCD。然后，他们被随机分配到研究组之一（CCD 或 SIMO）。SIMO 组的参与者在下颌中线接受了外部六棱柱种植体，并立即连接 O 形环/球附着体。在分配前和 6 个月和 12 个月随访时，评估两组的口腔健康相关生活质量（OHIP-EDENT）和患者满意度。使用意向治疗（ITT）和方案内分析进行分析。统计分析采用 Wilcoxon 符号秩检验和广义估计方程。
84 名参与者（CCD n=42；SIMO n=42）被纳入研究，其中 70 名完成了 12 个月的随访（CCD n=34；SIMO n=36）。ITT 分析显示，与基线相比，CCD 组在纵向评估中没有变化。SIMO 组的 OHIP-EDENT 评分和对下颌义齿的满意度有显著改善。两组的上颌义齿均无变化。当进行方案内分析时，得到了相似的结果。
与 CCD 相比，SIMO 治疗显著改善了患者的感知结果。对于适应不良和/或不稳定的下颌义齿患者，SIMO 可被视为替代治疗方法（ClinicalTrials.gov NCT03463174）。
在 12 个月的随访后，即刻加载的单种植体下颌覆盖义齿显著提高了传统义齿佩戴者的满意度和口腔健康相关生活质量。
