Oraqix has been extensively researched and evaluated for safety and efficacy.
In this section you can access published articles for each of six studies that have been conducted with Oraqix. The data from these six studies are the basis for the FDA's approval of Oraqix. There are differences between the abstracts, the completed published articles and the summary that appears in the full prescribing information. Important information relating to contraindications, warnings, precautions, adverse reactions, dosage, and administration are not included in the published abstracts. Please refer to the full prescribing information.
Oraqix is contraindicated in patients with hypersensitivity to amide type local anesthetics or any other product component. The most common adverse reactions in clinical studies were application site reactions, headaches and taste perversion. Post-marketing experience has shown a low incidence of allergic reactions, including skin rashes, gingival redness and swelling, laryngeal edema and anaphylactic reactions.
The Anesthetic onset and duration of a new lidocaine/prilocaine gel intra-pocket anesthetic (Oraqix®) for periodontal scaling/root planing
- Johan Friskopp, Marie Nilsson and Goran Isacsson,
Journal of Clinical Periodontology 2001
"A new non-injection anesthetic, lidocaine/prilocaine gel (Oraqix®) in a reversible thermosetting system, has been developed to provide local anesthesia for scaling/root planing (SRP)..." download PDF for more
Plasma levels of lidocaine and prilocaine after application of Oraqix®, a new intrapocket anesthetic, in patients with advanced periodontitis
- Johan Friskopp and Gunilla Huledal,
Journal of Clinical Periodontology 2001
"Oraqix®, a new non-injection local anesthetic, lidocaine/prilocaine gel 5%, has been developed to provide pain relief in association with periodontal probing and scaling/root planing (SRP)..." download PDF for more
A placebo-controlled multi-centered evaluation of an anesthetic gel (Oraqix®) for periodontal therapy
- D. Donaldson, S.C. Gelskey, R.G. Landry, D.C. Matthews
and H.S. Sandhu, Journal of Clinical Periodontology 2003
"Six Canadian dental schools investigated the ability of a thermosetting gel containing 25 mg/g prilocaine and 25 mg/g lidocaine as active agents to produce analgesia in periodontal pockets..." download PDF for more
Intrapocket Anesthesia for Scaling and Root Planing: Results of a Double-Blind Multicenter Trial Using Lidocaine Prilocaine Dental Gel
- Marjorie K. Jeffcoat, Nico C. Geurs, Ingvar Magnusson,
Simon R. MacNeill, Nancy Mickels, Frank Roberts,
Peter Robinson, Afshin Salamati, and Ray Yukna,
Journal of Periodontology July 2001
"The efficacy of a novel anesthetic gel (lidocaine 25 mg/g plus prilocaine 25 mg/g in thermosetting agents) for non-invasive periodontal pocket anesthesia was evaluated..." download PDF for more
Intrapocket Anesthesia for Scaling and Root Planing in Pain-Sensitive Patients
- Ingvar Magnusson, Nico C. Geurs, Pearl A. Harris,
Arthur F. Hefti, Angelo J. Mariotti, Sally M. Mauriello, Lina Soler,
and Steven Offenbacher, Journal of Periodontology May 2003
"In 2 previous multicenter studies evaluating the efficacy of a novel anesthetic gel (lidocaine 25 mg/g plus prilocaine 25 mg/g), there was a rather small, although statistically significant overall difference between the active and placebo gels..." download PDF for more
Patient Evaluation of a Novel Non-Injectable Anesthetic Gel: A Multicenter Crossover Study Comparing the Gel to Infiltration
- Daniel van Steenberghe, Pierre Bercy, Jan De Boever,
Patrick Adriaens, Lut Geers, Elke Hendrickx, Christian Adriaenssen,
Eric Rompen, Maria Malmenas, and Joakim Ramsberg,
Journal of Periodontology November 2004
"Periodontal scaling procedures commonly require some kind of anesthesia. From the patient's perspective, the choice of anesthetic method is a trade-off between the degree of anesthesia and accepting the side effects..." download PDF for more