An interventional study of Self Adjusting File in Teeth, Endodontically-Treated, sponsored by ReDent Nova. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-11.
Sponsored by ReDent Nova · Not applicable, Interventional, and Treatment
The study's primary goal is to assess the safety of the SAF (Self Adjusting File) device for root canal treatments.
The study's secondary goal is to evaluate the effectiveness of the SAF device for root canal treatments
Endodontic treatment (root canal treatment) is conducted when the dental pulp is inflamed or when it becomes necrotic and infected. The main cause for both these cases is dental caries and they represent sequential stages of the same disease with inflammation preceding the necrosis and infection.
Mechanically, both conditions are treated in a rather similar manner, by "cleaning and shaping", using endodontic files and irrigation solutions. This mechanical process is aimed to thoroughly disinfect the root canal by removing all tissue remnants while enlarging the diameter of the root canal, to remove all canal irregularities that may harbor bacteria. During this process an inner layer of dentin has to be removed from all the surface of the root canal. A second goal of root canal treatment is to allow adequate sealing of the canal space by a root canal filling, in order to prevent future bacterial contamination. For teeth with inflamed vital pulps, once this stage is completed the root canal may be sealed. When necrotic infected root canals are involved, this stage greatly reduces the bacterial load in the canal but an additional stage of disinfection by medicaments, sealed in the canal until the next appointment, may be required.
The SAF file is an endodontic file designed to be operated by a Profin dental low-speed hand-piece (W\&H, Burmoos / Salzburg, Austria), which converts rotation into a transline reciprocal movement. The active part of the file is manufactured from a thin-walled tube of medical grade nickel-titanium alloy. It has a cylindrical shape and can be compressed to allow its insertion into thin root canal, due to its lattice-like structure.
The SAF file is an endodontic file of a revolutionary design. As any endodontic file it is designed to remove dentin from the root canal walls and enlarge the canal. Its advantages are:
The tested device is an engine-operated endodontic file used for root canal treatment. It is constructed from a medical grade nickel-titanium alloy and designed as a hollow tube made of a delicate metal lattice, attached to a dental hand-piece. It is operated in root canals with a continuous rinsing. The rinsing solution enters the hollow device through a special irrigator attachment, flows through the root canal and emerges through the access cavity, where it is collected using a dental suction tip.
113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.
Browse Tooth, Nonvital studies →This is the only study on the registry with ReDent Nova as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment related operative and postoperative major complications.
Time frame: One year.
Healing of pariapical leasions as a result of the endodontic treatment.
Time frame: One year.
This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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