The aim of this clinical trial was to test the effectiveness of high-fluoride toothpaste (5000 ppm F) on root caries lesions in adults and to test the hypothesis that high concentration fluoride tooth- paste would effectively improve the surface hard- ness in root caries lesions in adult patients.
Adult patients (18-75yrs) with 10 or more natural teeth and at least at least one root caries lesion in an uncrowned or compromised tooth were eligible for recruitment. Patients were randomised to high-fluoride (5000 ppm) toothpaste or regular-fluoride toothpaste (1350 ppm) given specific instructions on brushing (2mins, twice daily) and strictly instructed to refrain from using toothpastes or toothbrushes other than the ones provided
The primary outcome measure was the changes in the surface structure of the root caries lesions after the intervention using a clinical texture scale; Level 1: Hard ; Level 2: Hard to Leathery; Level 3: Leathery ; Level 4: Leathery with local softening ; Level 5: Soft. Surface hardness scores (HS) were recorded at, baseline, 3 and 6 months. The mean HS was calculated for each subject by dividing the sum of individual surface scores by the number of surfaces scored.
- 135 patients were randomised (67 test; 68 control)
- 5 patients were lost to follow-up (3 test; 2 control)
- ANOVA revealed significantly better HS for the test group than for the control groups at 3 months (Test HS = 2.9 ± 0.67; Control HS = 3.1 ± 0.75) and
- 6 months (Test HS = 2.4 ± 0.81; Control HS = 2.8 ± 0.79; P < 0.0001).
The authors concluded:-
The application of a high-fluoride containing dentifrice (5000 ppm F) in adults, twice daily, significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride containing (1350 ppm F) toothpastes.
Acknowledgements:- This trial was supported by the Colgate-Palmolive Company.
This study does suggest a statistical benefit at both 3 and 6 months from the use of 5000ppm toothpaste. However, the authors do highlight a number of issues in their discussion. It was not possible to provide identical packages of test and control pastes so patients would have been aware of their group assignment – although the outcome assessors were blind. The power sample indicated a sample size of 90 per group although a difference was demonstrated between the groups. As with most trials this was a highly selective group and the questions about whether these findings can be generalised also needs to be considered. While we have strong evidence of the effectiveness of toothpastes in children and adolescents only a small number of studies have been conducted in adults. While this study suggests a benefit from the use of higher fluoride toothpaste in adults in the short term we need more information to better inform our adult patients on the their use.
Srinivasan M, Schimmel M, Riesen M, Ilgner A, Wicht MJ, Warncke M, Ellwood RP, Nitschke I, Müller F, Noack MJ. High-fluoride toothpaste: a multicenter randomized controlled trial in adults. Community Dent Oral Epidemiol. 2013 Dec 20. doi: 10.1111/cdoe.12090. [Epub ahead of print] PubMed PMID: 24354454.