Donald R. Mehlisch

Evaluation of collagen/hydroxylapatite for augmenting deficient alveolar ridges: A preliminary report

A multicenter study was undertaken to evaluate a new alveolar ridge augmentation material composed of purified fibrillar collagen and particulate hydroxylapatite (PFC/HA). In a study of 77 patients and 99 reconstructed ridges, this material provided superior handling properties over HA alone as evidenced by its ease of surgical placement and manipulation, and the rarity of particle migration or displacement. Moreover, the rapid development of ridge firmness and stability allowed for the loading of dentures within three to six weeks. Prosthodontist evaluations and surveys of patient satisfaction showed great satisfaction with denture fit, comfort, esthetics, speech, and ability to masticate.

Intranasal Ketorolac for Pain Secondary to Third Molar Impaction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

PURPOSE This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of intranasal (IN) ketorolac in patients who had third molar extraction surgery with bony impactions. MATERIALS AND METHODS After surgery, patients were randomly assigned to receive IN ketorolac 31.5 mg (n = 40) or IN placebo (n = 40). Safety was assessed from spontaneously reported adverse events and measurement of vital signs. Efficacy assessments included pain intensity, which was measured on a 0- to 100-mm visual analog scale, total pain relief, and global pain evaluation up to 8 hours after dosing or until patients required rescue analgesia. The primary efficacy variable was the summed pain intensity difference score over the first 8 hours after dosing. RESULTS Summed pain intensity difference values +/- SE were significantly higher (indicating better analgesia) in the ketorolac group compared with placebo (136.7 +/- 33.0 vs -105.2 +/- 29.1, P < .001). Total pain relief scores were significantly higher (P < .001) in the ketorolac group compared with placebo at all times. A larger proportion of subjects in the ketorolac group reported good, very good, or excellent pain control compared with the control group (60% vs 13%). Times to perceptible (21.5 minutes) and meaningful (66.0 minutes) pain relief were significantly shorter and the time to rescue analgesic use was significantly longer in the ketorolac group (P < .001). Eight patients in the placebo group and 3 in the ketorolac group had adverse events, none of which was serious. The 3 events in the ketorolac group were reports of mild headache. CONCLUSION A single IN ketorolac 31.5 mg dose was well tolerated and provided rapid and effective pain relief in oral surgery patients for a period up to 8 hours.

Single Doses of Parecoxib Sodium Intravenously Are as Effective as Ketorolac in Reducing Pain After Oral Surgery

PURPOSE Our goal was to compare the analgesic efficacy and safety of single doses of intravenous parecoxib sodium, a prodrug of the novel cyclooxygenase (COX)-2-selective inhibitor valdecoxib, with intravenous ketorolac and placebo in postoperative oral surgery patients. PATIENTS AND METHODS Eligible patients experiencing moderate to severe pain within 6 hours of surgery to extract 2 or more impacted third molars were randomized to receive a single dose of parecoxib sodium 1, 2, 5, 10, 20, 50, or 100 mg; ketorolac 30 mg; or placebo. Analgesic efficacy was assessed over a 24-hour treatment period or until rescue analgesia was required. RESULTS Parecoxib sodium doses (particularly 50 and 100 mg) had a rapid onset of analgesia (within 11 minutes). The analgesic efficacy of parecoxib sodium 20 to 100 mg was similar to that of ketorolac 30 mg. Parecoxib sodium doses below 20 mg had suboptimal analgesic activity compared with placebo and ketorolac. A plateau of efficacy was observed at the parecoxib sodium 50-mg dose. Parecoxib sodium 50 and 100 mg had a significantly longer duration of analgesia than ketorolac 30 mg. All doses of parecoxib sodium were well tolerated. CONCLUSIONS Parecoxib sodium, a novel parenteral prodrug of the COX-2-selective inhibitor valdecoxib, is as effective and longer acting at 50- and 100-mg intravenous doses than a standard dose of ketorolac 30 mg intravenously. Parecoxib sodium appears to be safe and well tolerated and, therefore, merits further evaluation in other models of postsurgical pain.

Collagen/hydroxylapatite implant for augmenting deficient alveolar ridges: twelve-month clinical data.

In a multicenter study, 77 edentulous patients had mandibular augmentation with implants of purified fibrillar collagen combined with dense hydroxylapatite (Alveoform Biograft); 22 of these patients also had maxillary augmentation. Most patients had Class III or IV mandibular atrophy, and had outpatient surgery with the subperiosteal tunneling technique. Temporary splints were worn for 24 hours post-surgery. Mean ridge height was 15.3 mm before surgery and 19.5 mm after 12 months, an augmentation of 4.2 mm. Predictable compaction occurred largely in the first few months after denture loading. Most patients, surgeons, and prosthodontists assessed the results of the procedure as good to excellent at 1 year following implantation. Adverse experiences, largely dehiscence and paresthesia, tended to resolve over time. Sera from ten patients demonstrated antibodies to bovine collagen that were not clinically significant. Alveolar augmentation with collagen/hydroxylapatite achieved clinically significant results that compared favorably with those achieved with other types of ceramic implants.

The time to onset and overall analgesic efficacy of rofecoxib 50 mg: a meta-analysis of 13 randomized clinical trials.

Objective: To determine the time to onset of analgesia of rofecoxib based on a patient-level meta-analysis of randomized, placebo-controlled, postoperative oral surgery pain studies. Methods: A search on MEDLINE and of Merck data on file was conducted to identify studies that met the inclusion criteria. Meta-analysis inclusion criteria required that patients were treated with a single oral dose of rofecoxib 50 mg when they experienced moderate or severe pain after surgical extraction of ≥2 third molars; study design involved patient randomization, double-blinding, and matching placebo, and onset data from individual patients were available. The meta-analysis of time to onset also required that studies used the two-stopwatch method. Eleven studies fulfilled the onset criteria and included patients who received a single dose of rofecoxib 50 mg (N = 1220) or placebo (N = 483). These studies were analyzed to determine time to onset of analgesia, time to perceptible pain relief, percentage of patients achieving onset of analgesia, and duration of analgesia. Six of the 11 studies included a nonselective nonsteroidal anti-inflammatory drug (N = 303) and were included in the onset meta-analysis for comparison. The meta-analysis of overall efficacy also required that data on total pain relief scores over 8 hours were available. Over-all effectiveness of analgesia was based on analysis of 13 studies involving 1330 rofecoxib patients and 570 placebo patients on the endpoints of total pain relief scores over 8 hours and patient global assessment of response to therapy at 24 hours. Eight of the 13 studies with a nonselective nonsteroidal anti-inflammatory drug comparator (N = 391) were included for the efficacy meta-analysis. Results: Patient demographics and baseline characteristics were similar across treatment groups in each study. Median time to onset of analgesia for rofecoxib was 34 minutes (95% CI, 31-38 minutes), significantly faster than placebo, which did not achieve onset within the 4 hours the assessment was conducted (P < 0.001). Duration of analgesia for rofecoxib 50 mg was >24 hours. Rofecoxib achieved a greater mean total pain relief score over 8 hours than placebo (17.4 versus 4.4; P < 0.001) and a greater patient response rate on patient global assessment of response to therapy at 24 hours than placebo (73% versus 16%; P < 0.001). Outcomes were similar between the rofecoxib group and the nonselective nonsteroidal anti-inflammatory drug group. Conclusion: In this meta-analysis of over 1200 rofecoxib-treated patients, a single dose of rofecoxib 50 mg demonstrated a rapid onset of analgesia in approximately half an hour combined with sustained effectiveness, supporting its use as a treatment of acute pain.