RESONATE v1.0
Research type
Research Study
Full title
A single-centre, randomised, 3-way cross-over, clinical investigation comparing denture fixative versus no fixative performance in full denture wearers and an exploratory sub-study in partial denture wearers.
IRAS ID
313158
Contact name
Sue Pavitt
Contact email
Sponsor organisation
Reckitt Benckiser Health Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
Summary of Research
Denture fixative creams are intended to fix full or partial dentures onto the gums of patients who have no or few natural teeth of their own. It is thought that the increase in denture retention reduces instability, provides comfort as well as chewing ability and eliminates the accumulation of food debris beneath the dentures.This study looks at how well two denture fixative creams (one currently available in the market; the other has been newly developed) perform compared to using no fixative and how well tolerated they are by patients wearing full or partial dentures.
Summary of Results
Our study started on 27 January 2023 and ended on 01 September 2023. The study consisted of a screening visit, followed by three treatment periods and a three -week observational period to monitor safety. 105 people were screened for the study and 24 of them did not meet the study’s eligibility criteria. In total, 75 of the eligible participants took part in the study: 56 full and 19 partial denture wearers. Only 11 participants had both full upper and lower dentures. The youngest participant was 26 years old and the oldest was 84 years old.Main study (full-denture wearers) findings:
Both denture fixatives showed a significant improvement in holding (retention) dentures in place one hour after applying them, compared to not using any fixative. This was tested on both full upper and lower dentures.Additional findings for full denture wearers:
• The fixatives also improved denture retention within just 5 minutes and after 30 minutes of applying them.
• The fixatives reduced slippage (stability) of the upper dentures at all times tested. For lower denture wearers, there was no improvement in stability 30 minutes after the application of one denture fixative, whereas the other fixative showed reduced slippage. Please note that there were only 11 participants with full lower dentures, and so further studies are needed to determine if this is a reliable finding.
• Stronger retention was noted across all areas of the mouth with fixatives compared to no fixative.
• Participants experienced better hold, greater satisfaction, and more comfort for their gums with the fixatives.
• Participants reported significant improvement in their oral health related quality of life when they applied the fixatives compared to no fixative.
• Dentists reported good tolerance levels (no harm on gum health) for both fixatives.
• Testing the force needed to dislodge the dentures showed no difference between the two fixatives and the control (no fixative), likely due to limitations in the testing method.Safety
Both fixatives were found safe for both full and partial denture wearers. While there were some side effects reported, none were linked to the fixatives, and most were unrelated to treatment.Qualitative Sub-Study:
Interviews with the participants showed that the participants responded positively to the fixatives, noting improvements in their confidence when eating and speaking. Many reported feeling better psychologically and at social events.Sub-study with Partial Denture Wearers:
For participants with partial dentures, the results were similar to full denture wearers, supporting the safety and performance (how well it works) of both fixatives.Conclusion:
The study found that both denture fixatives are safe and work well when used as directed. Participants benefited without any major issues.Please note that the outcome of this study is from the results of this study only. Other studies may show something different.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0138
Date of REC Opinion
30 Oct 2022
REC opinion
Favourable Opinion