Objective To assess the effectiveness and safety of tinidazole buccal tablets produced by China Associate Pharmaceutical Co. , Ltd. on periodontitis and pericoronitis. Methods A mukicenter randomized controlled doubleblind trial was designed. Three units from Shanghai, Hangzhou and Chengdu joined the study. The trial tablet oftinidazole was supplied by the mentioned Pharmaceuticals company. A marketed tinidazole produced by Zhejiang Hacon Marine BioPharmaceutical Co. Ltd. , was used as positive control. Both drugs were administered at a dose of 5 mg four times daily for 6 days. Outcomes measurement included symptoms, clinical signs of the patients with periodontitis or pericoronitis, and gingival index （GI）, bleeding index （BI）, plaque index （PI） and periodontal depth （PD） were measured for the patients with periodontitis. Subgingival bacterial samples taken from subgingival plaque of diseased teeth of the cases with periodontitis or from exudates of diseased wisdom teeth of the cases with pericoronitis were cultivated aerobically and anaerobically. Putative microorganisms were isolated and colony forming unit （CFU） were counted before and after treatments. All adverse drug reactions （ADIL） were observed, recorded, properly treated and followed. Results Altogether, 157 cases met the inclusion criteria and entered the study. Lost to follow-up happened in 14 cases with drop-out rate of 8.9%. In per-protocal cases there were 109 with periodontitis （57 in trial group and 52 in control group） and 34 with pericoronitis （17 in trial group and 17 in control group）. Basehne analysis demonstrated that the two groups were comparable. At the final examination, it was found that 85% of the cases in the periodontitis group showed significant）mprovement gingival bleeding, both gingival pain and biting pain subsided, PD, BI, GI and PI reduced with no significant difference between trial and control groups （P 〉0.05）. The symptoms of sixty percent of cases with pericoronitis were improved. More than 75% of the cases with pericoronal pus, the pus were ehminated. Over 60% of the cases with lymphadenitis, the node swelling was subsided. Mouth opening increased in all cases with pericoronitis. All improvements in the cases with pericoronitis showed no significant difference between trial and control groups （ P 〉0.05 ）. The effective rate only including cured and markedly improved cases reached 88.2% in both groups of pericoronitis. Various species of putative microorganisms were detected in patients with periodontitis or pericoronitis before treatment. A great proportion of the putative microorganisms eliminated or the quantity reduced after treatment, with no significant difference between trial and control groups （P 〉0.05 ）. Candida albicans was not detected before and after treatment. Nine patients developed ADRs, 5 （6.8% ）in trial group and 4 （5.8% ）in control group. All the ADRs were mild and transient, not interfering with drug administration. Conclusions This study showed the tinidozole buccal tablet with commercial name “Jinhe” supphed by China Associate Pharmaceutical Co. , Ltd. do inhibit the common putative microorganisms of periodontitis and pericoronitits, and do not influence balance of the local commensal microganisms. It reduces severity of the infectious inflammation and benefits improvement and/ or rehabilitation of periodontitis and pericoronitis, with only mild and transient ADRs. The trial and control tablets have similar efficacy and safety for patients with periodontits or pericoronitis.
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.