Asymptomatic Diseases Clinical Trial
Official title:
The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial
Orthognathic surgery is the state of art of the maxillofacial surgery, it fix and normalize
facial abnormalities and create a harmony between the different tissues compounding the face
(bone, soft tissue and dental structures). It is a common procedure and it is done in order
to correct a dentofacial and skeletal deformities.
There is an inevitable risk of complications with this type of surgery. While postoperative
infections are the most common complication (2% to 33.4%).
preoperative administration of antibiotics have been proven to be effective in reducing the
postoperative infection rate, while, the quality of the currently available literature in
prescribing continues postoperative antibiotics is questionable and there is still no
consensus on its efficacy.
Unwise administration of antibiotics may cause several unwanted side effects such as
gastrointestinal symptoms, allergy reactions, high costs, etc… while the most worrisome side
effect is a bacterial resentence.
The objective of this study is to investigate the efficacy of postoperative antibiotics. And
will try to state a consensus in prescribing postoperative antibiotics. By conducting a
prospective, randomized, double-blind, placebo-controlled study, that will explore and
analyze the efficacy of postoperative administration of Amoxicillin Clavulanate versus
placebo in reducing the rate of postoperative infections in 60 healthy patients.
The first Orthographic operation was carried out in 1849, for the correction of
malocclusions, in the United States of America. Back then, this surgery was merely a
mandibular operation and was called Hullihen's procedure done by general surgeons. However,
the first cooperation between surgeons and orthodontists in the evolution of the early
orthognathic surgery was cradled in St. Louis by the orthodontist Edward Angle (1898) and
the surgeon Vilray Blair (1906). During the 19th orthognathic surgery underwent minor
improvements, never the less, not until the beginning of the 1950s, when orthognathic
surgery was deemed as a true specialty had its origins, which led to tremendous success all
over the world. Nowadays, orthognathic surgery is performed not only for correcting dental
and skeletal deformities, but also is conducted as a treatment of various congenital and
cranio-facial syndromes, such as Crouzon syndrome, Treacher syndrome and Apert's syndrome.
However, orthognathic surgery is not an innocent procedure, since it contains several
complications. Pain, swelling, neurosensory deficits and post operative infections are the
most common complications. While postoperative infection is the most common one, with a 2%
to 33.4% percentage of occurrences. Postoperative infections increase the mortality rate of
orthognathic procedure and may create a challenge for the surgeon and the medical staff,
thus, reducing its prevalence is critical issue in defining the success of this unique
procedure.
Preoperative prophylaxis has been proven as an efficient in decreasing the rate of
postoperative infections in orthognathic surgery.
While the current literature regarding the efficacy of postoperative antibiotics
questionable and there is still no consensus on its efficacy.
This study is a prospective, randomized, double-blind, placebo-controlled study that will
investigate the efficacy of postoperative antibiotics. And will try to state a consensus in
prescribing postoperative antibiotics.
Objectives and Goals of the study:
The main goal of the present study is to evaluate the efficacy of post operative antibiotics
in decreasing the rate of postoperative infections in orthognathic surgery.
Secondary objectives are to state and formulate a consensus in prescribing postoperative
antibiotics.
Study Design:
The current study is a prospective, double blind, randomized, placebo control, clinical
trial.
The impact of post-operative antibiotics in prevention early surgery related infections will
be investigated. The potential benefit of the study lies particular in reducing the various
side effects of unwise administration of antibiotics, along with the high cost and bacterial
resistant resulted from antibiotics overuse.
The study subjects will be allocated by the investigator into two study groups through the
use of randomization. The Intervention group will be getting intra-venous1GR Amoxicillin
Clavulanate 3 times a day for 5 days post surgery; while the Control group will be getting
intra-venous Placebo for 5 days.
As described above, 50 patients will participate in this study, an important prerequisite
for this study is a completely healthy patients. Then the patients will be allocated
randomly into two subgroups: intervention group and control group, as mentioned before.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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