Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment
Recruitment status was: Not yet recruiting
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Using the Endodontic Self Adjusting File - SAF for Root Canal Treatment|
- 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. ]
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:
- it grinds the inner root canal wall, rather than machine-cut it,
- it adapts itself to the cross section of the canal and enlarges it to a wider version of its original form.
- It enlarges the canal; using one instrument which gradually expands in size, rather than tediously using a sequence of instruments.
- Its hollow space allows for continuous irrigation and flushing out the ground material rather than tediously stopping again and again to remove the instrument from the root canal and flush it, and
- it is highly resistant to breakage
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497042
|Tel Aviv Souraski Medical Center|
|Tel Aviv, Israel|
|Principal Investigator:||Amnon Singer, DMD||Redent Nova Ltd.|