Clinical Study of a Formulation Containing Phtalox® in Periodontal Disease

Plain-language summary

Periodontitis is a chronic and destructive inflammation that leads to the loss of tissue supporting the teeth, the periodontium, and possibly tooth loss and edentulism. Its etiology is related to an overload on the host's defense mechanisms, consequent to the accumulation of plaque or suppression of the immune system. Standard treatment for periodontitis includes scaling and root planing (RAR) and possible association with therapeutic adjuvants such as systemic and local antimicrobials. However, the use of these drugs supporting the treatment of periodontitis, has shown adverse effects such as loss of taste, soft tissue burn, pain, xerostomia, supragingival calculus formation and change in staining of teeth, restorations, prostheses and tongue. Other effects not as common as mucosal ulcerations, desquamative lesions, urticaria, dyspnea, anaphylactic shock and swellings reversible effects in the parotid glands and lips have also been observed and reported in the literature. Thus, there is a need for new adjuvant therapies, which cause less effects side effects and that are more effective in the treatment of periodontitis and in the maintenance of oral health. The commercial product PHTALOX® is a phthalocyanine dental mouthwash that has a spectrum of action based on the formation of reactive oxygen that acts by inhibiting odor-causing substances, on microorganisms and on the mechanisms of coagulation and healing. Your supporting action in periodontal treatment may have promising potential. Thus, the purpose of this study clinical trial will be testing a formulation containing PHTALOX® for disease prevention and control Periodontal (PD). 30 patients will be recruited who will undergo scaling and straightening coronaroradicular (RAR), and after basic periodontal treatment will be randomly divided into 3 groups according to the supporting treatment: G1 - patients who will receive mouthwashes with physiological solution; G2 - patients who will receive 0.12% chlorhexidine mouthwash; G3 - patients who will be treated with PHTALOX®. Clinical reassessments of patients will be carried out before the treatments, and at 15, 30 and 60 days after the performance of the RAR and beginning of the respective mouthwash. After data collection, intra and intergroup analyzes will be performed comparing the therapeutic results for the periodontal condition through the "Bioestat" program.

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