Effect of toothpaste on tooth plaque and sensitivity
Research type
Research Study
Full title
A Clinical Study Investigating the benefits of a hydroxylapatite /potassium nitrite and aluminium lactate cosmetic toothpaste to help the discomfort associated with Dentine Hypersensitivity compared to a benchmark marketed toothpaste.
IRAS ID
266661
Contact name
Nicola West
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
ISRCTN13889391
Duration of Study in the UK
0 years, 10 months, 9 days
Research summary
Research Summary
This single centre, double blind, parallel, randomised controlled design study will investigate the benefits of a hydroxylapatite /potassium nitrite and aluminium lactate cosmetic toothpaste to help the discomfort associated with dentine hypersensitivity compared to a benchmark marketed toothpaste, Sensodyne Daily Care.
The study will be conducted in subjects in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
Summary of Results
Toothpastes containing aluminium lactate have been shown to help plaque reduction and promote healthy gums, but there is now some limited evidence that they may also help reduce the pain of dentine hypersensitivity.
This study aimed to determine how effective a cosmetic toothpaste containing aluminium lactate/potassium nitrate/hydroxylapatite was at reducing the pain of dentine hypersensitivity as compared to a similar cosmetic control toothpaste that also contained potassium nitrate.
The study was a randomised, examiner-blind, two treatment arm, parallel controlled trial in healthy adults with at least 2 sensitive teeth as measured by Schiff sensitivity score. Participants fulfilling eligibility criteria who gave informed consent were randomised to either test (aluminimum lactate) or control toothpaste. Prior to using their allocated toothpastes and then immediately after use, and after 7 and 14 days twice daily use their plaque and sensitivity were measured. In the whole mouth plaque levels were measured by a standard plaque index, sensitivity was measured by patient reported VAS and dentine hypersensitivity quality of life was assessed by questionnaire. The sensitivity of the 2 identified sensitive teeth was assessed using 2 triggers of dentine hypersensitivity, a tactile trigger and an ice cold thermal trigger and the participant response to each recorded by examiner determined Schiff score and Yeaple probe force together with a participant reported VAS score.
The study took place between 3rd August and 7th October 2020 and recruited 82 participants, 42 randomised to the test and 40 to the control group. All participants that were recruited to the study completed it. The results showed that the sensitivity of the 2 sensitive teeth improved in both groups following treatment, but that in the group receiving the test treatment pain scores improved significantly more at all time points that those recorded for the control group. No significantly differences were recorded for global sensitivity or dentine hypersensitivity oral health quality of life, however scores favoured the test toothpaste. No differences in plaque scores were observed between the groups, but both groups maintained a good level of oral health.
This study demonstrated the efficacy of an aluminium lactate/potassium nitrate/hydroxylapatite toothpaste compared to a potassium nitrate control toothpaste for the prevention of dentine hypersensitivity both immediately and over a 2 week period. This agent appears to have potential for pain alleviation from the common oral pain condition of DH and further research is warranted.REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0036
Date of REC Opinion
24 Feb 2020
REC opinion
Favourable Opinion