A Randomized Controlled Trial On Testing A New Vertical Dimension Of Occlusion Prior To Restorative Treatment Of Generalized Tooth Wear
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Interventions on restorations
研究概览
简要总结
This study is a Randomized Controlled Trial (RCT). The aim of the study is to evaluate the necessity to test the desired increased Vertical Dimension of Occlusion (VDO) prior to restorative treatment of generalized tooth wear.
Tooth wear is a physiological phenomenon, that when becoming pathological, can result in functional problems such as pain, reduced quality of life and esthetic impairment. Restorative treatment should be discussed with patients with severe or pathological tooth wear.
The restorative treatment of generalized tooth wear includes restoration of teeth, separately, in increased VDO. The increment of VDO is based upon clinical parameters such as the amount of natural tooth tissue, the possibility to lengthen the anterior teeth in regard to an acceptable esthetics outcome, and the Free Way Space (FWS). The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed.
Traditionally, it is believed that adapting to a new VDO results in clinical difficulties such as different speech, pain of the Temporo Mandibular Joint (TMJ), masticatory muscle pain, and increased masticatory muscles activity. The latter could result in an increased bite force and (possibly) an increased failure rate of restorations. Some operators, then, prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO. This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment. The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the restorative treatment.
Patients with generalized severe tooth wear were included and restoratively treated with composite restorations. Prior to restorative treatment, patients were randomized to either receiving an acrylic Removable Appliance (RA) or no RA. The RA was worn for 3 weeks prior to restorative treatment and included the intended increment of VDO. These patients were asked to wear the RA during the whole day, except when eating.
After restorative treatment, patients revisited our dental clinic after 1 month and after 1 year. Quality of life was assessed with questionnaires. FWS was assessed clinically. Restorations were checked for clinical acceptability, including small materials fractures.
详细描述
This study is a Randomized Controlled Trial (RCT). The aim of the study is to evaluate the necessity to test the increased Vertical Dimension of Occlusion (VDO) prior to restorative treatment of generalized tooth wear.
Tooth wear is a physiological phenomenon, that when becoming pathological, can result in functional problems such as pain, reduced quality of life and esthetic impairment. Restorative treatment should be discussed in with patients with severe or pathological tooth wear.
The restorative treatment includes restoration of all teeth, separately, in increased VDO. The increment of VDO is based upon clinical parameters as the amount of loss of natural tooth tissue, the possibility to lengthen the maxillary anterior teeth in regard to an acceptable esthetic outcome, and the Free Way Space (FWS). The FWS is the intermaxillary space when the masticatory-muscles-complex is relaxed.
Traditionally, it is believed that adapting to a new VDO results in clinical difficulties such as different speech, pain of the Temporo Mandibular Joint (TMJ), masticatory muscle pain, and increased masticatory muscles activity. The latter could result in an increased bite force and an increased failure rate of restorations. Some operators, then, prefer to test the increment of VDO prior to restorative treatment to check if patients can adjust to the new VDO. This raises the question if the needed increment of VDO to restore worn dentitions should be checked prior to restorative treatment. The hypothesis in this study is that testing the needed increment of VDO prior to restorative treatment does not improve the adaptation to the restorative treatment.
The research was registered in the ClinicalTrial.gov register after the study had been completed. This RCT is part of RCT with a 2x2 design. The first branch was used to randomize patients to certain restorative protocol, which was enlisted in ClinicalTrials.gov (NCT04326816). The second branch was designed to test the VDO prior to restorative treatment of generalized severe tooth wear. Approval of the local Medical-Ethics-committee (METC) for the 2x2 RCT was sought and granted in 2010. Approval was granted to a protocol in which no Data Safety Monitoring Board was appointed as research standards were different in 2010. The study was conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Generalized moderate to severe tooth wear with patient demand for treatment
- •Full dental arches, one diastema due to one missing posterior tooth was allowed
- •Estimated need for an increase in VDO of at least 3 mm in the first molar region
排除标准
- •Limited mouth opening
- •(History of) Temporomandibular dysfunction
- •Advanced periodontitis, deep caries lesions, or multiple large restorations including teeth with endodontic problems
- •Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with Gastro-Oesophageal Reflux Disease (GORD), were not excluded.
结局指标
主要结局
Interventions on restorations
时间窗: Baseline, recall after 1 month, recall after 1 year.
Number of interventions needed for patients to adjust to the increased VDO
次要结局
- Oral Health Impact Profile (OHIP) questionnaire(Baseline, Recall after 1 month, recall after 1 year.)
- Orofacial Esthetic Scale (OES) questionnaire(Baseline, Recall after 1 month, recall after 1 year.)
- Free Way Space(Baseline, Recall after 1 month, recall after 1 year.)
