Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- progression of non-cavitated proximal caries lesions
研究概览
简要总结
The aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression.
Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard preventive treatments.
In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at each institution are to be treated with both, the infiltration technique and using conventional fluoridation treatment in different sides of the mouth ("split-mouth design").
The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration to prevent the progression of existing approximal carious lesions, and thereby enable an improvement in caries prevention within the scope of dental treatment.
详细描述
The aim of the planned in-vivo trial is to investigate the effectiveness of the the caries infiltration technique for the repression of approximal caries progression. .
Within the framework of this investigation it is intended that the hypothesis be substantiated that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard treatments.
Modern dentistry, which is focused more towards preventive and minimally invasive treatment, attempts - with the aid of fluoride therapies and improved oral hygiene - to prevent the onset and progression of carious lesions as much as possible.
Even today, approximal lesions pose a particular problem to the treating dentist. A primary reason for this is the difficulty accessing the localized area of the carious cavity. Treating this area usually requires invasive treatment, in which healthy tooth structure must be removed. Furthermore, it is possible that the filling material may deteriorate as a result of the aging process, meaning that the restoration will require replacement at some point in the future. In order to prevent this, the development of a treatment oriented towards prevention and minimal invasion is key.
For a number of years there has been an option to seal pits and fissures on the occlusal surfaces, which is assessed in the literature as being highly efficacious and effective (Splieth et al. 2010, Ahovuo-Saloranta et al. 2008, Griffin et al. 2008). It constitutes a vital component of the caries prevention approach especially in the event of an increased risk of caries (Hiiri et al. 2010). In recent years there has been an attempt to transfer this treatment concept to applications in the approximal area, in order to prevent unnecessary substance ablation. A fissure sealing resin and a dental adhesive were used for the first time in an attempt at creating a surface diffusion barrier (Gomez et al. 2008, Gomez et al. 2005, Paris et al. 2006, Martignon et al. 2006, Robinson et al. 2001). Coating the tooth surface in the approximal area with various plastic foils after tooth separation opened up a whole new treatment approach for dealing with these carious lesions (Alkilzy et al. 2010, 2009).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age: 18 years and older
- •Good general health
- •At least 2 active, approximal caries lesions present without evidence of frank cavitation Caries depth: E2 - D1 (minimum extension to the inner half of the enamel and maximum to the outer third of the dentin)
- •The posterior teeth on the upper and lower arches from distal of the first premolar to mesial of the second molar will be included
- •All teeth to be treated must have approximal contacts with the adjacent teeth in the arch
- •Other teeth requiring treatment will be treated prior to the beginning of the trial
- •The patients must declare their consent to participate in the clinical trial following the provision of the required clarifications regarding the method, significance and scope of the trial as well as the associated risks. They may withdraw this consent at any time.
- •Participation in the follow-up examinations
排除标准
- •- Parallel participation in a further trial relating to dental materials
- •The patient has not signed the participant consent form
- •Pregnant and breastfeeding women prior to the trial commencing A woman that becomes pregnant after the treatment has been performed will remain in the study, unless she becomes pregnant for a second time in which case, she will be excluded from the study
- •Unexplained diseases of the mucous membranes or conditions in the sense of contact allergies to materials used, e.g. oral lichenoid lesions
- •Known allergies to ingredients contained within the treatment materials used
- •Infectious diseases such as HIV, hepatitis, etc
- •Undergoing orthodontic treatment at the time of the trial
- •Persons who are presently taking other medication due to other illnesses, which upon our examination are deemed to possibly be a risk or a problem for the patient or the study
- •A large number of existing carious lesions that have not been restored and would require extensive treatment, comprehensive prosthetic restorations that need to be done or replaced and severe periodontal disease
- •Current use of bleaching products or use within the two weeks previous to the start of the study
- •No assured dry isolation possible as required per the criteria of the adhesive technology (rubber dam system)
- •Persons with a history of allergies
- •Patients with dental treatment phobias
结局指标
主要结局
progression of non-cavitated proximal caries lesions
时间窗: up to 36 months
preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size
次要结局
未报告次要终点