BACKGROUND: Non-steroidal anti-inflammatory agents inhibit the production of cyclooxygenase (COX) products and can attenuate bone loss. In this double-masked, placebo-controlled, randomized clinical trial, the efficacy of celecoxib (COX-2 inhibitor) was evaluated in conjunction with scaling and root planing (SRP) in subjects with chronic periodontitis (CP). METHODS:A total of 131 subjects were randomized to receive SRP and either celecoxib (200 mg) or placebo every day for 6 months. Clinical outcomes were assessed every 3 months for 12 months as mean changes from baseline. Primary efficacy parameters included clinical attachment level (CAL) and probing depth (PD). Secondary outcomes included percentages of tooth sites with CAL loss or gain > or =2 mm, changes in bleeding on probing (BOP), plaque index, and mobility. Prior to analysis, tooth sites were grouped based on baseline PD as shallow (1 to 3 mm), moderate (4 to 6 mm), or deep (> or =7 mm). RESULTS:Mean PD reduction and CAL gain were greater in the celecoxib group, primarily in moderate and deep sites, throughout the study (PD: 3.84 mm versus 2.06 mm, P <0.001; CAL: 3.74 mm versus 1.43 mm, P <0.0001 for deep sites at 12 months). The celecoxib group also exhibited a greater percentage of sites with > or =2 mm CAL gain and fewer sites with > or =2 mm CAL loss. Both groups showed improved plaque control and BOP scores. Demographic, social, and behavioral factors did not affect treatment outcomes. CONCLUSIONS:Celecoxib can be an effective adjunctive treatment to SRP to reduce progressive attachment loss in subjects with CP. Its beneficiary effect persisted even at 6 months postadministration. However, given the increased cardiovascular risks associated with the use of this drug, close patient supervision and strict adherence to dosage and administration guidelines established by the Unites States Food and Drug Administration are of paramount importance.
RCT Entities:
BACKGROUND: Non-steroidal anti-inflammatory agents inhibit the production of cyclooxygenase (COX) products and can attenuate bone loss. In this double-masked, placebo-controlled, randomized clinical trial, the efficacy of celecoxib (COX-2 inhibitor) was evaluated in conjunction with scaling and root planing (SRP) in subjects with chronic periodontitis (CP). METHODS: A total of 131 subjects were randomized to receive SRP and either celecoxib (200 mg) or placebo every day for 6 months. Clinical outcomes were assessed every 3 months for 12 months as mean changes from baseline. Primary efficacy parameters included clinical attachment level (CAL) and probing depth (PD). Secondary outcomes included percentages of tooth sites with CAL loss or gain > or =2 mm, changes in bleeding on probing (BOP), plaque index, and mobility. Prior to analysis, tooth sites were grouped based on baseline PD as shallow (1 to 3 mm), moderate (4 to 6 mm), or deep (> or =7 mm). RESULTS: Mean PD reduction and CAL gain were greater in the celecoxib group, primarily in moderate and deep sites, throughout the study (PD: 3.84 mm versus 2.06 mm, P <0.001; CAL: 3.74 mm versus 1.43 mm, P <0.0001 for deep sites at 12 months). The celecoxib group also exhibited a greater percentage of sites with > or =2 mm CAL gain and fewer sites with > or =2 mm CAL loss. Both groups showed improved plaque control and BOP scores. Demographic, social, and behavioral factors did not affect treatment outcomes. CONCLUSIONS:Celecoxib can be an effective adjunctive treatment to SRP to reduce progressive attachment loss in subjects with CP. Its beneficiary effect persisted even at 6 months postadministration. However, given the increased cardiovascular risks associated with the use of this drug, close patient supervision and strict adherence to dosage and administration guidelines established by the Unites States Food and Drug Administration are of paramount importance.
Authors: Raimundo Fernandes de Araújo Júnior; Tatiana Oliveira Souza; Lígia Moreno de Moura; Kerginaldo Paulo Torres; Lélia Batista de Souza; Maria do Socorro Costa Feitosa Alves; Hugo Oliveira Rocha; Aurigena Antunes de Araújo Journal: PLoS One Date: 2013-10-10 Impact factor: 3.240