Multi-center randomized double-blind clinical trial on efficacy of a mouthwash containing 0.1% cetylpiridinium chloride on gingivitis and plaque and its safety_Chinese Journal of Evidence-Based Medicine

Authors：

SHI Zongdao ¹ , ZHOU Xuedong ¹ , WANG Xiaoyi ¹ , XIAO Xiaorong ¹ , DING Yi ¹ , HUANG Dingming ¹ , WU Junzheng ² , ZHOU Wei ² , LIU Bin ² , YANG Jucai ² , CUI Guangqing ³ , QIN Yuhua ³ , WU Donghong ³ , LUO Yu ⁴ , LIU Guanjian ⁵

1. West China Stomatological Hospital of Sichuan University; Chengdu 610041; China2. Stomatological Hospital of Fourth Military University; Xian 710032; China3. He’nan Provincial Hospital, Zhengzhou 450003, China 4. He’nan Provincial Medical Research lnstitute, Zhengzhou 450003, China5. Department of Clinical Epidemiolog, West China Medical Center of Sichuan University, Chengdu 610041, China;

Corresponding author：

Keywords：

Cetylpiridinium chloride; gingivitis; plaque; treatment efficacy; safety; randomized double blind clinical trial

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

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.

Citation： SHI Zongdao,ZHOU Xuedong,WANG Xiaoyi,XIAO Xiaorong,DING Yi,HUANG Dingming,WU Junzheng,ZHOU Wei,LIU Bin,YANG Jucai,CUI Guangqing,QIN Yuhua,WU Donghong,LUO Yu,LIU Guanjian. Multi-center randomized double-blind clinical trial on efficacy of a mouthwash containing 0.1% cetylpiridinium chloride on gingivitis and plaque and its safety. Chinese Journal of Evidence-Based Medicine, 2003, 03(3): 171-177. doi: Copy

1.	［1］孙鸿祺,陈菊滟,陈文娟,赵桂芳,黄修院自制与进口氯化十六烷基吡啶抑菌作用的比较研究[J].上海铁道医学院学报1995;9(3):151-155.
2.	［2］Nelson RF, Rodasti PC, Tichnor A, Lio YL.Comparative study of four over-the-counter mouthrinses claiming antiplaque and/or antigingivitis benefits[J].Clin Prev Dent 1991;13(6):30-33.
3.	［3］Allen DR, Davies R, Bradshaw B, Ellwood R, Simone AJ, Robinson R, Mukerjee C,Petrone ME, Chaknis P, Volpe AR, Proskin HM.Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults[J]. Compend Contin Educ Dent 1998;19(2 Suppl):20-26.
4.	［4］曹采方牙周病学[M].第一版北京:人民卫生出版社.2000:85-87.
5.	［5］Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic[J]. Arzneimittelforschung 2001 ;51 (7):588-595.
6.	［6］Vermooten CAL. Effect of cepacol solution on oral bacterial flora in chidren with pharyngitis and tonsillitis[J]. Curr Ther Res 1977;21(6):893-897.
7.	［7］Holbeche JD, Ruljancich MK, Reade PC. A clinical trial of the efficacy of a cetylpyridinium chloride-based mouthwash. 1. Effect on plaque accumulatin and gingival condition[J]. Aust Dent J 1975;20(6):397-404.
8.	［8］Moran J, Addy M, Jackson R, Newcombe RG.Comparative effects of quaternary ammonium mouthrinses on 4-day plaque regrowth[J]. J Clin Periodontol2000 ;27(1):37-40.
9.	［9］Allen DR, Davies R, Bradshaw B, Ellwood R, Simone AJ, Robinson R, Mukerjee C,Petrone ME, Chaknis P, Volpe AR, Proskin HM.Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults[J]. Compend Contin Educ Dent 1998; 19(2 Suppl):20-26.
10.	［10］Walsh TF.Mouthrinses as adjuncts in periodontal therapy[J]. Dent Update 1996 ;23(4): 144-147.
11.	［11］van Steenberghe D, Avontroodt P, Peeters W, Pauwels M, Coucke W,Lijnen A,Quirynen M. Effect of different mouthrinses on morning breath[J]. J Periodontol 2001 ;72(9): 1183-1191.

1. ［1］孙鸿祺,陈菊滟,陈文娟,赵桂芳,黄修院自制与进口氯化十六烷基吡啶抑菌作用的比较研究[J].上海铁道医学院学报1995;9(3):151-155.
2. ［2］Nelson RF, Rodasti PC, Tichnor A, Lio YL.Comparative study of four over-the-counter mouthrinses claiming antiplaque and/or antigingivitis benefits[J].Clin Prev Dent 1991;13(6):30-33.
3. ［3］Allen DR, Davies R, Bradshaw B, Ellwood R, Simone AJ, Robinson R, Mukerjee C,Petrone ME, Chaknis P, Volpe AR, Proskin HM.Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults[J]. Compend Contin Educ Dent 1998;19(2 Suppl):20-26.
4. ［4］曹采方牙周病学[M].第一版北京:人民卫生出版社.2000:85-87.
5. ［5］Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic[J]. Arzneimittelforschung 2001 ;51 (7):588-595.
6. ［6］Vermooten CAL. Effect of cepacol solution on oral bacterial flora in chidren with pharyngitis and tonsillitis[J]. Curr Ther Res 1977;21(6):893-897.
7. ［7］Holbeche JD, Ruljancich MK, Reade PC. A clinical trial of the efficacy of a cetylpyridinium chloride-based mouthwash. 1. Effect on plaque accumulatin and gingival condition[J]. Aust Dent J 1975;20(6):397-404.
8. ［8］Moran J, Addy M, Jackson R, Newcombe RG.Comparative effects of quaternary ammonium mouthrinses on 4-day plaque regrowth[J]. J Clin Periodontol2000 ;27(1):37-40.
9. ［9］Allen DR, Davies R, Bradshaw B, Ellwood R, Simone AJ, Robinson R, Mukerjee C,Petrone ME, Chaknis P, Volpe AR, Proskin HM.Efficacy of a mouthrinse containing 0.05% cetylpyridinium chloride for the control of plaque and gingivitis: a 6-month clinical study in adults[J]. Compend Contin Educ Dent 1998; 19(2 Suppl):20-26.
10. ［10］Walsh TF.Mouthrinses as adjuncts in periodontal therapy[J]. Dent Update 1996 ;23(4): 144-147.
11. ［11］van Steenberghe D, Avontroodt P, Peeters W, Pauwels M, Coucke W,Lijnen A,Quirynen M. Effect of different mouthrinses on morning breath[J]. J Periodontol 2001 ;72(9): 1183-1191.

Chinese Journal of Evidence-Based Medicine

Multi-center randomized double-blind clinical trial on efficacy of a mouthwash containing 0.1% cetylpiridinium chloride on gingivitis and plaque and its safety

Abstract Full text Figures/Tables Video References Cited by

Format

Content