Tooth, Deciduous Clinical Trial
Official title:
A Comparative Clinical and Radiographic Study of 3Mixstatin vs Tri-Antibiotic Mix and Simvastatin in the Treatment of Primary Molars With Inflammatory Root Resorption A Randomized Clinical Trial
The aim of this study is to determine whether the success rate of pulp therapy undergone on primary molars with signs and symptoms of odontogenic infection that may render them indicated for extraction will improve with the use of the Simvastatin alone, the Tri-Antibiotic Mix alone or when in combination together 3Mixstatin as a component in the root filling material.
A clinical situation will often present itself where primary teeth under radiographic
examination show inter-radicular or periapical root resorption, perforation of coronal third
of roots and/or loss of bone support as a result of infective or inflammatory conditions.
Pathologic root resorption is the most common cause of premature tooth loss in primary
dentition. The reason for that may be the high content of undifferentiated mesenchymal cells,
which may give rise to odontoclastic cells in response to either the caries process or the
pulp-capping materials, resulting in the exaggerated inflammatory response and consequently
internal resorption in primary teeth. It would make sense to utilize the rich supply of
undifferentiated mesenchymal cells towards regeneration of remaining dental tissues.
Antibiotic Mix as an intracanal medicament
In recent years, the Cariology Research Unit of Niigata University School of Dentistry has
developed the concept of lesion sterilization and tissue repair (LSTR) therapy that employed
a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected
if lesions are disinfected. This procedure uses a mixture of three antibacterial drugs (3Mix
MP) as a root canal medicament to eliminate the remaining bacteria in endodontic lesions. The
medicament consists of metronidazole, ciprofloxacin and minocycline - with macrogol (M) as
the ointment base and propylene glycol (P) as the carrier Alone, none of these drugs resulted
in complete elimination of the bacteria. However, in combination, these drugs were able to
consistently sterilize all samples.
Although a local antibiotic medication in endodontics offers many advantages, this mode has
some drawbacks, including development of bacterial resistant strains. That is a major concern
and may lead to the transfer of resistance genes from antibiotic-resistant to
antibiotic-susceptible microorganisms. Other drawbacks include allergic reactions inhibition
of angiogenesis , and tooth staining or discoloration particularly with Minocycline. More
importantly is that although the concept of Lesion sterilization and tissue repair (LSTR)
therapy is that it provides an efficient and predictable disinfection, through 3 Mix on a
local level and providing the suitable environment for tissues to heal, it does not in itself
have any anti-inflammatory nor regenerative potential. Statins may provide these two benefit.
Choice of comparator Statins are structural analogs of HMG-CoA
(3hydroxy-3-methylglutaryl-coenzyme A). These drugs are the first-line for hyperlipidemia and
it has been recognized to be a safe and low-priced drug as a result of its worldwide longtime
usage. Moreover, statins have multiple functions including anti-inflammation, induction of
angiogenesis and improvement of the vascular endothelial cell function. Another interesting
and important function of statin is its effect on bone formation. It has been reported that
several statins such as simvastatin and lovastatin have anabolic effects on bone metabolism
at in vitro and in vivo studies. They promote mineralization in non-mineralizing osteoblasts
through induction of BMP-2 and osteocalcin. Local application of simvastatin gel has shown to
stimulate the regeneration of alveolar bone defects Statins have an anti-inflammatory effect.
They act by decreasing the production of interleukin-6 and interleukin-8 and may also improve
the function of odontoblasts, thus dentin formation.
3 Mixstatin as an intracanal medicament
Often, different chemicals or drugs are combination in a cocktail in an attempt to elicit
variety of effects with a single application.
Aminabadi et al combined the above-mentioned techniques by adding simvastatin powder to the
tri-antibiotic mix (3Mix) and proposed the term "3Mixtatin", (an acronym of 3Mix and
simvastatin) with the aims of suppressing bacteria, preventing pulp inflammation, and
inducing hard tissue formation. His study population involved poor prognosis primary molars
with advanced root resorption and/or pulpal floor perforation.
When compared with MTA, radio graphic and clinical healing occurred more successfully
following 3Mixtatin treatment within a 24-month study period 96.8% success rate both
clinically and radiographically. 3Mixstatin, a previously unstudied combination was applied,
lead to preservation of the primary teeth that were otherwise indicated for extraction
according to current guidelines. It may lead to a paradigm shift in the treatment of primary
teeth in the future.
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