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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
A placebo-controlled multi-centred evaluation of an anaesthetic gel (Oraqix) for periodontal therapy.
Journal of Clinical Periodontology 2003 March
AIMS: 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 utilizing a randomized, double-blind, placebo-controlled study.
MATERIALS AND METHODS: The study consisted of 130 patients, each of whom received the active or placebo gel in periodontal pockets in one quadrant of the mouth for 30 s prior to periodontal debridement (scaling and root planing). Pain was measured using both a 100-mm Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS).
RESULTS: The median VAS pain score for the patients treated with the anaesthetic gel was 5 mm (range 0-85 mm) as opposed to 13 mm (range 0-79 mm) in the placebo-treated patients (P=0.015). There was no significant difference in the percentage of patients reporting no or mild pain (78% and 76% for the anaesthetic gel and placebo, respectively). No significant differences were seen in patient demographics, or mandible versus maxilla.
CONCLUSIONS: The VAS pain scores showed that the anaesthetic gel 5% was statistically more effective than the placebo in reducing pain during periodontal debridement.
MATERIALS AND METHODS: The study consisted of 130 patients, each of whom received the active or placebo gel in periodontal pockets in one quadrant of the mouth for 30 s prior to periodontal debridement (scaling and root planing). Pain was measured using both a 100-mm Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS).
RESULTS: The median VAS pain score for the patients treated with the anaesthetic gel was 5 mm (range 0-85 mm) as opposed to 13 mm (range 0-79 mm) in the placebo-treated patients (P=0.015). There was no significant difference in the percentage of patients reporting no or mild pain (78% and 76% for the anaesthetic gel and placebo, respectively). No significant differences were seen in patient demographics, or mandible versus maxilla.
CONCLUSIONS: The VAS pain scores showed that the anaesthetic gel 5% was statistically more effective than the placebo in reducing pain during periodontal debridement.
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