| Objective: Periodontitis is a local infective disease caused by microorganisms of the periodontal pocket,which initially induced by aggregation of microorganisms on dental plaque. Nowadays, routine periodontal treatment is initial therapy aided with chemotherapy, and the ideal pharmaceutics used on periodontitis should meet the requirement of local high pharmaceutical concentration, long lasting time and low side-effects. Shuanghuangbu sustained-release preparation could release slowly in vitro, and has also been proved can effectively inhibit inflammation and enhance the regeneration of periodontal tissue. To explore this kind of sustained-release preparation, combining Chinese herbal medicine with local delivery technique, is the orientation of chemotherapy of periodontitis. This clinical trial displayed the actual concentration of Beberine Hydrochloride and Baicalin, which are effective ingredients of Shuanghuangbu, in GCF by HPLC at different time. Then the clinical effects of Shuanghuangbu sustained-release preparation were evaluated by detecting the flow of GCF and the level of PGE2 in GCF.Methods: 21 systemically healthy patients with moderate to severe periodontitis (male 10, female 11) were recruited. To qualify, subjects were required to have at least one periodontal pocket with probing depth of 5mm to 9 mm which bled on gentle probing on each side of the mouth.1 The release of Shuanghuangbu in vivo.We selected 7 patients (male 3,female 4) randomly from the subjects, and divided the 16 sites into trail and control groups. One week after the initial therapy, we set Shuanghuangbu sustained-release preparation and Shuanghuangbu preparation respectively in periodontal pocket, then collected GCF sample at different time, determined the concentration of Beberine Hydrochloride and Baicalin in GCF.2 Shuanghuangbu sustained-release preparation in chronic periodontitisWe selected 14 patients (male 7,female 7) randomly from the subjects, and divided the 40 target sites into trail and control groups. A week after the initial therapy (at baseline), all target sites were taken GCF for measuring the quantity of GCF and the level of PGE2 in GCF. Three clinical parameters including probing depth, attachment loss and bleeding on probing were examined for each site. At baseline all the patients received subgingival scaling and root planning. The trial group was followed by 3-time application of Shuanghuangbu with five-day interval, and no medicine was applied in the control group. 3 days after the treatment ended, the examination was the same as the procedure of baseline. Results1 The release of Shuanghuangbu in vivo0.5 hour after the Shuanghuangbu preparation was put into the pocket, the concentration of Beberine Hydrochloride and Baicalin in GCF was 303.41μg/ml and 168.55μg/ml;2.5h later, the concentration of the two ingredients decreased rapidly to 15.99μg/ml and 3.00μg/ml,When it comes to the trial group, the concentration of Beberine Hydrochloride and Baicalin in GCF was 1177.03 μg/ml and 1474.40μg/ml respectively 0.5 hour after the Shuanghuangbu sustained-release preparation was applied;24 hours after the application, the concentration of Beberine Hydrochloride in GCF was 142.79μg/ml ,while it of Baicalin dropped to 2.12μg/ml;96 hours after the preparation was used, the concentration of Beberine Hydrochloride was 9.32μg/ml.2 Shuanghuangbu sustained-release preparation in chronic periodontitis①At baseline, there were no statistically significant differences between the trial and the control group in clinical parameters(PD,AL,BOP(+)%),the flow of GCF and the level of PGE2 in GCF(P>0.05,t test and chi-square test).② The trial and the control group showed a decrease in PD and AL after treatment (P<0.01,paired-sample t test),and the former produced a more significant decrease in PD than the latter(P<0.05,t test).③ After treatment, there was a significant decrease in BOP(+)% in both the trial and the control group(P<0.05, chi-square test), the trial g... |
PDF Full Text Request