IADR Abstract Archives
CSPS Toothpaste Does Not Consistently Improve Gingival Health Versus Placebo
Objectives: To evaluate the effectiveness of toothpastes containing 5% calcium sodium phosphosilicate (CSPS) in controlling plaque and gingivitis.
Methods: Two sequential 12-week, randomised (stratified by baseline Gingival Index [GI] score), controlled, examiner-blind, parallel-group studies were conducted in healthy subjects with mild–severe gingivitis and plaque accumulation. Study 1: 331 subjects were randomised to (i) a 5% CSPS/sodium lauryl sulphate (SLS) toothpaste (relative dentine abrasivity [RDA] ~140); (ii) a 0% CSPS/SLS placebo (RDA ~131); or (iii) a negative control (silica, SLS; 923 ppm fluoride as NaF; RDA ~90). Study 2: 254 subjects were randomised to (i) a 5% CSPS/SLS toothpaste (RDA ~140); (ii) a 5% CSPS/SLS toothpaste (RDA ~100); (iii) a 5% CSPS toothpaste with cocamidopropyl betaine/sodium methyl cocoyl taurate (RDA ~100); (iv) a 0% CSPS/SLS placebo (RDA ~100); or (v) Study 1 negative control. All experimental and placebo toothpastes contained 927 ppm fluoride as sodium monofluorophosphate. Subjects brushed their teeth for 1 minute using the allocated toothpaste twice daily. After 6 and 12 weeks, gingival health was assessed using the GI and the Gingival Severity Index (GSI); plaque was assessed using the Turesky Plaque Index (TPI).
Results: Study 1: mean GI, GSI and TPI scores were statistically significantly in favour of the 5% CSPS/SLS toothpaste compared with placebo and negative-control toothpastes at both 6 and 12 weeks (all p<0.05). Study 2: the mean TPI score at Week 12 was significantly improved for the negative-control toothpaste compared with the 5% CSPS/SLS toothpaste (RDA ~100) (p<0.01); no other significant between-treatment differences were observed in TPI, GI or GSI scores. All treatments were generally well tolerated.
Conclusions: While in Study 1 the 5% CSPS-containing toothpaste demonstrated an advantage in maintaining gingival health over a non-CSPS toothpaste, this was not repeated with the three similar 5% CSPS-containing toothpastes in Study 2.
Methods: Two sequential 12-week, randomised (stratified by baseline Gingival Index [GI] score), controlled, examiner-blind, parallel-group studies were conducted in healthy subjects with mild–severe gingivitis and plaque accumulation. Study 1: 331 subjects were randomised to (i) a 5% CSPS/sodium lauryl sulphate (SLS) toothpaste (relative dentine abrasivity [RDA] ~140); (ii) a 0% CSPS/SLS placebo (RDA ~131); or (iii) a negative control (silica, SLS; 923 ppm fluoride as NaF; RDA ~90). Study 2: 254 subjects were randomised to (i) a 5% CSPS/SLS toothpaste (RDA ~140); (ii) a 5% CSPS/SLS toothpaste (RDA ~100); (iii) a 5% CSPS toothpaste with cocamidopropyl betaine/sodium methyl cocoyl taurate (RDA ~100); (iv) a 0% CSPS/SLS placebo (RDA ~100); or (v) Study 1 negative control. All experimental and placebo toothpastes contained 927 ppm fluoride as sodium monofluorophosphate. Subjects brushed their teeth for 1 minute using the allocated toothpaste twice daily. After 6 and 12 weeks, gingival health was assessed using the GI and the Gingival Severity Index (GSI); plaque was assessed using the Turesky Plaque Index (TPI).
Results: Study 1: mean GI, GSI and TPI scores were statistically significantly in favour of the 5% CSPS/SLS toothpaste compared with placebo and negative-control toothpastes at both 6 and 12 weeks (all p<0.05). Study 2: the mean TPI score at Week 12 was significantly improved for the negative-control toothpaste compared with the 5% CSPS/SLS toothpaste (RDA ~100) (p<0.01); no other significant between-treatment differences were observed in TPI, GI or GSI scores. All treatments were generally well tolerated.
Conclusions: While in Study 1 the 5% CSPS-containing toothpaste demonstrated an advantage in maintaining gingival health over a non-CSPS toothpaste, this was not repeated with the three similar 5% CSPS-containing toothpastes in Study 2.