Trios 2
Research type
Research Study
Full title
A study to investigate the impact of behavioral change modification using 3D intra-oral gingival imaging combined with a toothpaste indicated for gingivitis, to deliver an optimized standard of care to improve health.
IRAS ID
295336
Contact name
Nicola West
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
ISRCTN34705602
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
Summary of research
Gum disease is a prevalent condition which with good oral hygiene at home and regular visits to the dentist can be reversed. However, in most people if gum disease is not treated it progresses to periodontitis which is irreversible and can lead to tooth loss and have a negative impact on quality of life. There is also now evidence to suggest that periodontitis may increase the risk of an increasing number of other diseases such as heart disease, diabetes and Alzheimer's.Summary of Results
This study aimed to test a complex intervention for its ability to improve gum health. Participants with gum disease were randomised to either the complex intervention or control. The complex intervention comprised images generated by 3-dimensional scans of participants mouths before and after toothbrushing, which were used when giving oral hygiene advice to the participant, together with a toothpaste formulated for gum disease and regular texts with tips/reminders about how to improve gum health. For the control: scans of participants mouths were taken, but oral hygiene advice was delivered without these, using standard techniques and the group was asked to continue with their normal oral hygiene routine.
For all participants, gum health (dental plaque scores and gum bleeding) was measured at the first visit when they were randomised, and then at visits after 3 weeks, 3 months and 6 months.
The study showed that the group who received the complex intervention improved their bleeding scores significantly more than those in the control group at all study timepoints. Data for dental plaque was also better for the complex intervention group and was always significant on the inside surfaces of the teeth which can be harder to reach/clean well. On the outer surfaces of the teeth dental plaque scores were alwas better in the complex intervention group, but the difference was not always significant.
The results indicate that the complex intervention improved gum health more than control, and the differences seen between the tooth surfaces (inside compared to outside), suggest that it was not just a result of the toothpaste as this would reach all tooth surfaces, so must also be due to beneficial effects of showing participants the scans of their own mouths when giving oral hygiene advice.
The control group were shown their scans on the final study visit after all study measurements had been taken and given oral hygiene advice using these.The reason that gum disease is so prevalent is that many people do not have a good oral hygiene regime. They often do not brush their teeth effectively enough or know how they should be brushing even though they have had advice when they have visited the dentist.
New techniques that dentists can use to help people improve their oral hygiene regime at home are therefore important. 3D Intra oral scanners can now take very accurate pictures of the teeth and gums and could be used as an aid to help patients understand how to clean their teeth and to motivate them to clean better.
The aim of the study is to find out if using 3D intra oral scans along with associated oral hygiene advice and a toothpaste designed for healthy gums can improve overall gum health, more than the use of standard oral hygiene advice given without the aid of the 3D intra oral scans and with the participants preferred / normal toothpaste and brush regime.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
21/ES/0036
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion