Proximal Caries Clinical Trial
Official title:
Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment
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.
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).
The caries infiltration technique constitutes an additional new treatment concept. Here, the
surface alone is not exclusively coated but a diffusion barrier is instead created inside
the cavity itself, through the penetration of the "infiltrant" into the carious lesion
(Paris et al. 2010, Meyer-Lueckel et al. 2010, 2009, 2008, Phark et al. 2009). In current
studies, it has been possible to demonstrate inhibition of the progression of carious
lesions with the infiltration technique, both in bovine teeth in situ and in artificially
generated carious lesions in human teeth in vitro (Paris et al. 2010).
The development of the infiltration technique started back in the 1970's with the first
low-viscosity plastic materials. However, these were never put into clinical application due
to their toxicity (Robinson et al.1976). During their course of development, adhesive
systems were employed for sealing carious lesions (Donly et al. 1992, Garcia-Godoy et al.
1997). These also exhibit a caries-inhibiting effect. However, it has only been possible to
determine limited penetration depths. The reason for this is the surface morphology of the
carious cavity, with a very limited pore volume on the surface, and the characteristics of
the adhesive itself (Paris et al. 2007). In order to facilitate removal of the limiting
surface layer, a hydrochloric acid gel was used for the infiltration technique in place of
orthophosphoric acid gel for the adhesive technology. Using this conditioner it was possible
to guarantee better penetration of the materials up to a depth of 58 µm due to an erosive
removal of the surface layer (Meyer-Lueckel et al. 2007, Paris et al. 2007, 2009). In order
to better utilize the capillary effect in the altered surface and to thereby increase the
penetration depth of the material, monomer mixtures were developed with a high penetration
coefficient. These enable a fast penetration of the infiltrant into the altered carious
surface up to a depth of 750 µm (Paris et al. 2007, 2009). The sealing of the carious cavity
is now no longer restricted to the surface alone, but also encompasses the body of the
cavity.
The anticipated result of this trial shall deliver information on the long-term
effectiveness of caries infiltration and thereby result in an improvement in caries
prevention within the scope of dental treatment, and prevent the progression of existing
carious lesions . This is a micro-invasive form of treatment, which largely facilitates the
delay or avoidance of conventional invasive initial dental treatment with the associated
inevitable loss of healthy tooth structure. Further studies on the optimization of the
infiltration technique can be built upon these results. In the long-term, it will be
possible to use these findings to develop new prevention and treatment options for
approximal carious lesion .
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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