Objective To assess efficacy of mepivacaine on local anesthesia in dentistry and oral surgery and its safety. Methods Parallel group, stratified randomization, double blinded, muti-center clinical trial was designed. Two percent lidocaine with adrenaline in same cartridge was as control. Healthy patients with deep decay, pulpitis needed operative dentistry, or indication for extraction of the teeth, which located in the maxilla or front part of the mandible were included. Results Except 17 cases, 127 patients fulfilled inclusion criteria: 66 in treatment group and 61 in control group, dental filling for 60 and extraction for 67 cases, male 55 and female 72, average at 38.84 + 12.06 years. Submucous infiltration of 1.5 ml mepivacaine at labial or buccal side of the alveolar process produced onset of anesthesia in the median of 60 seconds which was same as that of lidocaine, anesthesia duration for 146.7 minutes with the median of 125 minutes, permitting painless filling or extractions. In the treatment group 81.82% freed of pain, while 15.15% had slight pain but received no extra local anesthetic for implementation of the treatment procedures, making the successful rate of 96.97%. In the mepivacaine group, 13.64% of the cases had transient elevation of the systolic pressure to the level of 145-162 mmHg, 8.33% diastolic pressure to the level of 91-93 mmHg. Only one case had transient palpitation in half minute after one minute injection of the drug with no medical care needed. All the cardiovascular reactions might result from adrenaline containing in the injections. Conclusion Mepivacaine is an effective, safe and reliable anesthetic agent for dentistry and oral surgery.
Objective To assess efficacy of a mouthwash containing 0.1% cetylpiridinium on gingivitis and plaque and its safety. Methods Multi-center randomized double-blind trial with positive control and split-mouth comparison was designed. Scaling on teeth of left side were conducted at do then on those of right side at D8. The cases rinsed five times a day in same way with assigned agents. Efficacy was measured using before-after differences of clinical and microbial variables. Re-examinations were scheduled at D4 and D8. Brushing was refrained between D0 and D4, resumed between D4 and D8. Results There were 144 patients with gingivitis included, 4 lost follow up. Data of 69 cases in test group and 71 in control group could be analyzed. Baseline data analysis showed that distributions of sex, age and values of clinical and microbial variables in both groups were well comparable. At D4 plaque accumulations of the scaled side in both groups were in same level, and Gingival index (GI), sulcus bleeding index (SBI) and VAS for halitosis were significantly reduced. At D8 the measurements of plaque index (PI), GI, SBI and VAS of halitosis decreased significantly more than those of D4. More than half of the suspected pathogenic strains were eliminated and log value of its CFU/ml decreased significantly but at same level in both groups. The balance of intra-oral bacterial flora was not disturbed. Seventeen cases in test group (24.6%) had minor and transient adverse reactions related to the mouthwash. Antimicrobial tests in vitro confirmed that the test agent could kill or inhibit growth of the pathogenic bacteria involving with oropharyngeal infection, gingivitis, periodontal diseases and caries. Conclusion The mouthwash containing cetylpiridinium could inhibit plaque, reduce severity of gingivitis and halitosis, with acceptable minor adverse reactions, similar to those of the marketed cetylpiridinum solution.