Chlorhexidine with an anti discoloration system after periodontal flap surgery: a cross-over, randomized, triple-blind clinical trial.

摘要

The use of chlorhexidine (CHX) has been recommended for a number of clinical applications including plaque control in the post-operative period. However, the use of CHX is burdened by some side effects that could affect the compliance of the patient. The aim of this clinical trial was to evaluate the side effects, the staining in particular, the patient acceptance, and the efficacy of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.2% CHX alone, after periodontal flap surgery. MATERIAL AND METHODS: This single-centre, cross-over, triple-blind randomized clinical trial was carried out on 48 consecutive patients. After periodontal flap surgery, the patients were prescribed to rinse two times per day for 1 min for 1 week with 10 ml of test or control CHX, contained in anonymous bottles coded K or M and assigned randomly. No brushing and interdental cleaning of the surgical area was allowed. At week 1, after suture removal, patients received full-mouth prophylaxis and were given a second anonymous bottle, reversing the products, with the same instructions as at baseline. Patients resumed tooth-brushing but not interdental cleaning. At the end of week 2, prophylaxis was repeated, mouth rinsing was discontinued and patients resumed normal oral hygiene. At weeks 1 and 2, the following variables were recorded: presence of pigmentation, gingival parameters at the surgically treated sites (gingival inflammation, tissue inflammation around the sutures, gingival swelling and presence of granulation tissue), patient perception and acceptance of the 2 mouthwashes. RESULTS: Forty-seven patients completed the study. The difference between treatments related to gingival variables was not statistically significant. The test CHX caused consistently less pigmentations than the control CHX in all the evaluated areas of the dental surfaces (odds ratio (OR)=0.083 p<0.0001 in the incisal area, OR=0.036 p<0.0001 in the approximal area and OR=0.065 p<0.0001 in the gingival area). The CHX ADS was found to be more tolerated by patients than the control mouthwash and to cause less food alteration, less alterations to the perception of salt and to be less irritant for the oral tissues. CONCLUSIONS: (1) CHX ADS caused less pigmentation, was burdened by less side effects and was more agreeable than the control CHX; (2) CHX ADS was as effective as CHX without ADS in reducing gingival signs of inflammation in the post-surgical early healing phase; (3) the use of CHX ADS could be of value in treatment protocols in which the patient compliance with a CHX mouthwash prescription is relevant.