The Opioid Analgesic Reduction Study (OARS) Pilot: A Double-Blind Randomized Multicenter Trial.

BACKGROUND: With addiction rates and opioid deaths increasing, health care providers are obligated to help stem the opioid crisis. As limited studies examine the comparative effectiveness of fixed-dose combination nonopioid analgesia to opioid-containing analgesia, a comparative effectiveness study was planned and refined by conducting a pilot study. METHODS: The Opioid Analgesic Reduction Study (OARS) pilot, a stratified, randomized, multisite, double-blind clinical trial, was designed to test technology and procedures to be used in the full OARS trial. Participants engaged in the full protocol, enabling the collection of OARS outcome data. Eligible participants reporting to 1 of 5 sites for partial or full bony impacted mandibular third molar extraction were stratified by biologic sex and randomized to 1 of 2 treatment groups, OPIOID or NONOPIOID. OPIOID participants were provided 20 doses of hydrocodone 5 mg/acetaminophen 300 mg. NONOPIOID participants were provided 20 doses of ibuprofen 400 mg/acetaminophen 500 mg. OARS outcomes data, including pain experience, adverse effects, sleep quality, pain interference, overall satisfaction, and remaining opioid tablets available for diversion, were collected via surveys, electronic medication bottles, eDiary, and activity/sleep monitor. RESULTS: Fifty-three participants were randomized with 50 completing the OARS pilot protocol. Across all outcome pain domains, in all but 1 time period, NONOPIOID was better in managing pain than OPIOID (P < 0.05 level). Other outcomes suggest less pain interference, less adverse events, better sleep quality, better overall satisfaction, and fewer opioid-containing tablets available for diversion. DISCUSSION: Results suggest patients requiring impacted mandibular third molar extraction would benefit from fixed-dose combination nonopioid analgesia. KNOWLEDGE TRANSFER STATEMENT: Study results suggest fixed-dose nonopioid combination ibuprofen 400 mg/acetaminophen 500 mg is superior to opioid-containing analgesic (hydrocodone 5 mg/acetaminophen 500 mg). This knowledge should inform surgeons and patients in the selection of postsurgical analgesia.

Mechanisms of trigeminal nerve injuries.

Injuries to the trigeminal nerve branches are a known and accepted risk in oral and maxillofacial surgery. It is prudent for the practitioner to explain the risks to patients as part of the informed consent process and to recognize and document the presence of nerve injury postoperatively. Patients should be referred to a surgeon experienced in microsurgical techniques in a timely fashion for evaluation and possible surgical intervention if an injury is not resolving.

Single-dose vicoprofen compared with acetaminophen with codeine and placebo in patients with acute postoperative pain after third molar extractions.

PURPOSE: The purpose of this double-blind, randomized study was to compare the efficacy and safety of a single dose of the following medications: 2 tablets of Vicoprofen (ibuprofen 200 mg/hydrocodone 7.5 mg; Knoll Pharmaceutical Co, Mount Olive, NJ), 2 tablets ofp6 acetaminophen with codeine phosphate (acetaminophen 300 mg/codeine 30 mg), and 2 tablets of placebo in the management of moderate to severe postoperative dental pain after surgical extraction of at least one impacted mandibular third molar. PATIENTS AND METHODS: One hundred twenty-five patients (75 women, 50 men) participated in the study. The time of first perceptible pain relief and meaningful pain relief were measured using a stopwatch technique. Pain intensity and pain relief scores were recorded using standard verbal descriptors at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after dosing. At the conclusion of the study, patients completed a global evaluation for the effectiveness of the study medication. RESULTS: Both active treatments were superior to placebo for all analgesic measures. Pain relief scores were significantly better for Vicoprofen than placebo throughout the study and significantly better than for acetaminophen with codeine from 2 through 8 hours after dosing. The duration of analgesia (time to remedication) was significantly longer for Vicoprofen (median, 5.50 hours) compared with acetaminophen with codeine (median, 3.03 hours) and placebo (median, 1.00 hours). Mean global evaluation for Vicoprofen was significantly better than for placebo and acetaminophen with codeine. Overall, there were no significant differences in the adverse event profile among the 3 treatment groups. CONCLUSIONS: Vicoprofen was found to be an effective postoperative analgesic medication in the management of acute postoperative dental pain. Its total analgesic effect, duration of analgesia, and global evaluation were superior to acetaminophen with codeine and placebo in this study model.

Trigeminal nerve injuries.

Injuries to peripheral branches of the trigeminal nerve are relatively uncommon; however, they are fairly debilitating to the patient when they do occur. Treating clinicians should evaluate and document baseline neurosensory testing results on patients and perform serial examinations approximately every two weeks. If there are no changes after one month, consideration should be given for referral to an oral and maxillofacial surgeon trained in trigeminal nerve microsurgery. Many patients will go on to spontaneous recovery; however, a number will require microsurgery. It is prudent for the treating clinician to recognize, document and discuss the injury with the patient prior to referring to the oral and maxillofacial surgeon trained in microsurgery.

Adjunctive cervicofacial liposuction.

Submental liposuction is an adjunctive surgical procedure that allows for the relatively predictable soft tissue recontouring of the cervicofacial region (Figs. 13 to 17). It may be performed independently as an outpatient procedure under intravenous sedation or as an adjunctive procedure during orthognathic surgery. Surgical complications are rare and are usually preventable with appropriate patient selection and surgical technique. Submental liposuction is a useful tool for enhancing the esthetic benefits of orthognathic surgery.

Burning mouth syndrome.

Complaint of a burning mouth is an increasingly common problem in the aging population. This has remained an enigma for the treating clinician, because visible pathologic lesions or processes are usually not evident. Local, systemic and environmental causes must be assessed to elicit the predisposing factors. Some suggestions for managing burning mouth syndrome are offered.

Transmission of infectious disease in the dental setting.

Patients in the industrialized world are at low risk of acquiring nosocomial infections; nevertheless, several aspects of care in the hospital or clinic can place patients at risk from infectious disease transmission. Paramount to the prevention of disease is the strict adherence to universal precautions for all patients. Tuberculosis has again emerged as a potential epidemic capable of dramatic morbidity and mortality. The World Health Organization estimated that 22.6 million people were infected with HIV and that 50 million would be infected by the year 2000. The main types of viral hepatitis are hepatitis A through G. The chance of transmitting hepatitis B virus is higher than the chance of transmitting HIV. As knowledge regarding the pathophysiology and transmission of these diseases has increased in recent years, some insight has also been gained into the problems related to transmission of diseases between individuals. This paper will discuss the transmission of tuberculosis, hepatitis and HIV as related to the dental setting and health-care workers.

Graft-versus-host disease. Case report and discussion.

The graft-versus-host disease reaction is an immunologic consequence resulting from the grafting of immunocompetent cells from one individual to an immunocompromised host. The oral manifestations of this disease process include severe oral pain, xerostemia, ulcerative lesions, and mucositis. With appropriate history and diagnostic testing, these lesions can be differentiated from other oral diseases having similar clinical appearance.

Innervation pattern of the temporalis muscle.

The purpose of this article is to describe the neural anatomy of the temporalis muscle as dissected along the intramuscular temporal fascial plane. This sagittal plane is a natural cleavage plane of the muscle, which is explored along with its relationship to the deep temporal nerve. Eight temporalis muscle specimens were removed in their entirety from 8 preserved cadavers. The muscles were selected based on whether they were grossly intact prior to procurement for processing. The muscle specimens were then processed over a 3-month period using Sihler's staining technique. Muscle dissection was performed along the intramuscular fascial plane under an operating microscope, taking care to preserve the underlying nerve and arterial anatomy. Dissections demonstrated an anterior and posterior division of the deep temporal nerve running within the deep portion of the muscle below the intramuscular fascial plane. This fascial layer provided a natural dissection plane to expose and evaluate the underlying nerve and arterial anatomy. In all specimens the deep temporal artery originated with the anterior temporal nerve and then branched into an anterior and posterior division. The innervation density and nerve caliber of the anterior portion of the muscle was much greater than that of the posterior, correlating with a greater anterior muscle bulk. This may have implications in differences in fiber type and functional regionalization of the muscle. The results of this anatomic study support the finding of an anterior and posterior division of the deep temporal nerve within the deep portion of the temporalis muscle. In addition, differences in the innervation density and muscle bulk lend credence to the possibility of regional muscle specialization. The natural cleavage plane of the intramuscular temporal fascia may have clinical ramifications for temporalis myofascial flaps while preserving the underlying neural anatomy to allow for normal residual temporalis muscle function.

Wurzburg lag screw plate versus four-hole miniplate for the treatment of condylar process fractures.

PURPOSE: The purpose of this study was to compare the biomechanical stability of rigidly fixed condylar neck fractures using either a conventional four-hole miniplate system or the Wurzburg lag screw plate system. MATERIALS AND METHODS: Ten identical synthetic mandibles were used for this study. Simulated bilateral condylar neck fractures were fixed with the lag screw plate system on one side and the miniplate system on the other. The mandibles were loaded with an MTS servohydraulic testing machine at a rate of 1 cm/min until failure was reached. Data for resistance to motion and ultimate strength for each fixation device were compared by paired Student t-tests. RESULTS: The mean resistance to motion for the four-hole miniplate was 64.0 kg/mm (SD = 10.1; range = 52-94) and for the lag screw system was 80.2 kg/mm (SD = 24.0; range = 55 to 126). The mean failure strength was 4.0 kg (SD = 0.9) (range = 2.6 to 5.5) for the miniplate system and 5.0 kg (SD = 2.5; range = 3.4 to 7.2) for the lag screw system. The lag screw system was significantly (P < .05) better than the miniplate for both parameters measured. CONCLUSION: In laboratory testing using synthetic mandibles, the Wurzburg lag screw-plate fixation system proved superior to a four-hole miniplate system in regard to resistance to motion and failure strength. Clinical trials are necessary to substantiate these laboratory data and determine whether the system can be effectively applied by the surgeon.

Using fenestration technique to treat a large dentigerous cyst.

Dentigerous cysts are commonly encountered in the practice of dentistry and oral and maxillofacial surgery. Treatment modalities range from enucleation to marsupialization, and are based on the premise that the pathological process can be controlled locally with minimal injury to the adjacent host structures. In a child, however, loss of permanent tooth buds in the management of a large dentigerous cyst can be devastating. This article describes the technique of fenestration, which removes this entity and preserves the developing dentition.

Intramuscular temporalis fascia: a guide to procurement of temporalis myofascial flaps.

The purpose of this study is to demonstrate an intramuscular fascial layer within the temporalis muscle. This can be used as an inferior plane when developing a temporalis myofascial flap for temporomandibular joint reconstruction. The advantages of using this plane include relatively bloodless zone, adequate thickness of flap for reconstructive purposes, and residual temporalis muscle to prevent the temporal concavity deformity. Cadaveric and clinical examples are presented.

Guided tissue regeneration in dentistry.

Guided tissue regeneration (GTR) is a technique currently used in dentistry for periodontal surgery, oral surgery, implant dentistry and reconstruction of maxillomandibular defects. The basic premise for this technique is to allow for osseous regeneration prior to soft tissue migration into the area of interest. This is accomplished with the use of membranes that prevent the migration of the soft tissue element into the bony defect. This paper discusses current uses for GTR techniques and reviews some of the materials now available for this purpose.

Management of sickle cell/beta thalassemia patient with severe odontogenic infection.

The sickle cell diseases are caused by a genetic mutation in the hemoglobin molecule, resulting in the decreased ability to transport oxygen with subsequent clinical ramifications secondary to the sickling of the red blood cells. Routine dental and oral surgical management is possible in the office with adherence to basic principles, including hydration, oxygenation and adequate anesthesia/analgesia. The underlying pathophysiology and management protocols for the sickle diseases are discussed.

Methohexital infusion technique for conscious sedation.

PURPOSE: The purpose of this study was to evaluate a methohexital infusion technique for conscious sedation in oral surgical procedures. Patients were evaluated for recall, comfort, recovery, and surgeon's estimate of cooperation. MATERIALS AND METHODS: Twenty adult (mean age, 29 years) ASA I or II patients requiring various dentoalveolar procedures were entered into the study. Administration of 1.5 micrograms/kg fentanyl and 1 mg midazolam were given until sedation was achieved. An infusion of methohexital was started using 50 micrograms/kg/min and increased as needed to 75 micrograms/kg/min. Postoperatively, visual analog scales were used to evaluate the efficacy of the technique. RESULTS: The average total amount of methohexital infused was 257 mg for an average surgical time of 88 minutes. Recovery times were short and uneventful. Patients were cleared for discharge in under 35 minutes. No cardiac or respiratory side effects were noted other than a mild increase ( < 15%) in heart rate. Shivering and hiccoughing were noted in two and four cases, respectively. Recall of surgical events reported by patients was low and patient cooperation was high as reported by surgeons. CONCLUSION: The continuous infusion of methohexital for conscious sedation has been shown to be safe, effective, inexpensive, and well accepted by patients and surgeons.