6-month use of 0.2% delmopinol hydrochloride in comparison with 0.2% chlorhexidine digluconate and placebo. (I). Effect on plaque formation and gingivitis. 1998

J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
Department of Clinical Research, Biosurface AB, Malmö, Sweden.

A double-blind, randomised, 6-month clinical trial with parallel group design in 149 patients with gingivitis was conducted to study the efficacy and safety of delmopinol hydrochloride 2 mg/ml (0.2% w/v, Decapinol Mouthwash) used for partly supervised mouthrinsing in comparison with chlorhexidine digluconate 2 mg/ml (0.2% w/v, Hibitane Dental, ICI Pharmaceuticals, UK) and placebo as an addition to normal oral hygiene. Assessments of efficacy were performed using the plaque index and bleeding on probing (BOP). Delmopinol showed 22% lower plaque index scores than placebo after 3 months (p<0.01) and 13% lower scores after 6 months. The corresponding figures for chlorhexidine were 38% (p<0.001) and 38% (p<0.001) after 3 and 6 months, respectively. Bleeding on probing was reduced for delmopinol in comparison with placebo by 11% after 3 months and by 18% (p<0.05) after 6 months. For chlorhexidine the corresponding figures were 18% (p<0.01) and 22% (p<0.01) after 3 and 6 months, respectively. While chlorhexidine showed greater plaque reduction than delmopinol (p<0.01 at 6 months), no statistically significant difference was reached between these two solutions regarding BOP. Both active solutions showed an increased amount of dental calculus in comparison with placebo. A transient anaesthetic sensation in the oral mucosa and taste affection were commonly reported adverse events in both the delmopinol and the chlorhexidine groups. The number of patients withdrawn from treatment due to adverse events or lack of cooperation was 7 in the chlorhexidine group, 4 in the placebo group and 1 in the delmopinol group. The results showed that rinsing with either 0.2% delmopinol hydrochloride or 0.2% chlorhexidine digluconate twice daily for 60 secs for 6 months results in less plaque formation and gingivitis than rinsing with placebo. Mouthrinsing with the 0.2% delmopinol hydrochloride solution was well accepted in this study.

UI MeSH Term Description Entries
D006987 Hypesthesia Absent or reduced sensitivity to cutaneous stimulation. Hypesthesia, Tactile,Hypesthesia, Thermal,Hypoesthesia,Numbness,Impaired Sensation,Reduced Sensation,Hypesthesias,Hypesthesias, Tactile,Hypesthesias, Thermal,Hypoesthesias,Impaired Sensations,Reduced Sensations,Sensation, Impaired,Sensation, Reduced,Sensations, Impaired,Sensations, Reduced,Tactile Hypesthesia,Tactile Hypesthesias,Thermal Hypesthesia,Thermal Hypesthesias
D009025 Morpholines Tetrahydro-1,4-Oxazines,Tetrahydro 1,4 Oxazines
D009067 Mouthwashes Solutions for rinsing the mouth, possessing cleansing, germicidal, or palliative properties. (From Boucher's Clinical Dental Terminology, 4th ed) Mouth Bath,Mouth Rinse,Mouth Wash,Bath, Mouth,Baths, Mouth,Mouth Baths,Mouth Rinses,Rinse, Mouth,Rinses, Mouth,Wash, Mouth
D009910 Oral Hygiene The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health. Dental Hygiene,Hygiene, Dental,Hygiene, Oral
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002710 Chlorhexidine A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque. Chlorhexidine Acetate,Chlorhexidine Hydrochloride,MK-412A,Novalsan,Sebidin A,Tubulicid,Acetate, Chlorhexidine,Hydrochloride, Chlorhexidine,MK 412A,MK412A
D003728 Dental Calculus Abnormal concretion or calcified deposit that forms around the teeth or dental prostheses. Tartar,Calculus, Dental
D003773 Dental Plaque A film that attaches to teeth, often causing DENTAL CARIES and GINGIVITIS. It is composed of MUCINS, secreted from salivary glands, and microorganisms. Plaque, Dental
D003774 Dental Plaque Index An index which scores the degree of dental plaque accumulation. Dental Plaque Indexes,Dental Plaque Indices,Index, Dental Plaque,Indexes, Dental Plaque,Indices, Dental Plaque
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked

Related Publications

J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
June 1995, European journal of oral sciences,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
July 1997, Journal of clinical periodontology,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
March 1996, Journal of clinical periodontology,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
April 1992, Journal of clinical periodontology,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
February 1998, Acta odontologica Scandinavica,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
January 1991, Clinical preventive dentistry,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
July 1995, Journal of clinical periodontology,
J C Hase, and R Attström, and S Edwardsson, and E Kelty, and J Kisch
March 1984, Journal of clinical periodontology,
Copied contents to your clipboard!