The anti-erosion effects of two different toothpastes on tooth enamel

ISRCTN ISRCTN55245733
DOI https://doi.org/10.1186/ISRCTN55245733
Secondary identifying numbers 2014119
Submission date
02/04/2015
Registration date
15/04/2015
Last edited
08/07/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
One of the effects of the growth of the food and drinks industry is the huge increase in the consumption of soft drinks, fruit juices and sport drinks. Many drink products are acidic in nature, such as orange or grapefruit juice or certain fruit squashes and fizzy drinks. Such drinks, if taken in excess, will promote erosion of the tooth surface, erosion being a loss of tooth substance by a chemical process not involving bacterial. Stannous fluoride has been shown to provide some protection for the enamel against acid attack. This study tests whether a stannous-containing toothpaste is better compared to a conventional toothpaste.

Who can participate?
Healthy adults

What does the study involve?
Participants are randomly allocated to one of two groups. Each participant receives a stannous-containing toothpaste and a conventional toothpaste twice in a random order. The participants are asked to wear a device (palatal appliance) positioned in the roof of their mouth which contains 2 enamel samples. The palatal appliances are made specifically for each person and are similar in design to those used in orthodontic treatment. On each treatment day, participants are asked to rinse one of the study toothpastes around their mouth twice a day. They are also required to rinse their mouth with orange juice 4 times a day while wearing the appliance to replicate drinking soft drinks.

What are the possible benefits and risks of participating?
There is no direct immediate benefit to those taking part in this study. However, they may have helped in the development of a toothpaste with protective properties against damage done to the teeth by acids. Participants might find wearing the palatal appliance uncomfortable to begin with, but a clinician will be on hand to adjust the appliance accordingly. There is an extremely remote risk of transmission of prions to those taking part in the study, but this risk is not considered to be any higher than compared with having normal dental treatment. This research group have run over 50 similar trials over the past 27 years and no participant has ever had a problem. It is not expected that those taking part in the study will experience any side effects from the toothpaste formulations used in this trial. Since there is always the possibility that a rare or previously unknown side effect may occur in when somebody uses a new toothpaste, trained dental staff will be available in the Clinical Trials Unit should any negative effect occur.

Where is the study run from?
Trial study centre: Bristol Dental School and Hospital (UK)
Trial run from: University of Bristol (UK)

When is the study starting and how long is it expected to run for?
January 2015 to June 2015

Who is funding the study?
The Procter and Gamble Company (UK)

Who is the main contact?
Prof. N West

Contact information

Dr Nicola West
Scientific

Clinical Trials Unit (Periodontology)
Bristol Dental School and Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom

Study information

Study designSingle-centre double-blind randomised supervised-usage two-treatment four-period crossover trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleA clinical study to measure the anti-erosion properties of two dentifrices
Study objectivesThis study will evaluate the protective effects of a stannous-containing toothpaste compared to a conventional toothpaste by comparing the enamel protection efficacy (loss of tooth enamel as measured by surfometry) of two dentifrices in a 10-day in situ erosion model. This trial will evaluate the protective effects of stannous ions on sections of human enamel that are repeatedly subjected to a citric acid drink challenge. Loss of enamel will be evaluated and compared by the use of surfometry (profilometry).
Ethics approval(s)NRES South West - Exeter REC, 24/03/2015, ref: 15/SW/0028
Health condition(s) or problem(s) studiedEnamel erosion
InterventionParticipants will wear a palatal appliance that is positioned in the roof of their mouth and contains 2 enamel samples. Participants are asked to rinse one of the study toothpastes (a slurry of 3g toothpaste:10ml water) around for 60 seconds, twice per day. Participants are required to rinse their mouth with orange juice (250ml over a 10 minute period) 4-times a day. Participants are provided with toothpaste and a toothbrush to use at home from screening until the end of the study and will be required to brush their teeth twice per day, in the morning and in the evening.
Intervention typeOther
Primary outcome measureDental erosion measured by profilometry at baseline and Day 10
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date06/01/2015
Completion date30/06/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants36
Total final enrolment36
Key inclusion criteria1. Provide written informed consent to participate in the study, and receive a copy of the signed consent form
2. Agree not to participate in any other oral/dental product studies during the course of the study
3. Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed
4. Agree to refrain from the use of any non-study dentifrice or other oral hygiene products for the duration of the study
5. Agree to return for all scheduled visits and follow study procedures
6. 18 years and older
7. Agree to refrain from taking an acidic medication (pH <5.3) during the course of the study
8. Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study
Key exclusion criteria1. Susceptibility to acid regurgitation
2. Recurrent or regular aphthous ulcers
3. Dental erosion or a previous history of being susceptible to high dental erosion after drinking sports drinks or juices
4. Excessive gingival inflammation
5. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
6. Any pre-existing oral or medical condition that the examiner determines may place the subject at increased health risk from study participation
7. Non-removable mouth or tongue jewellery
8. Any subject who in the opinion of the investigator (or medically qualified designee) should not participate in the study
9. Personnel, i.e. an employee of the Sponsor, member of the Clinical Trials Unit at the Bristol Dental School and Hospital or family relative. Employees of the Bristol Dental School and Hospital or Bristol University not associated with the Clinical Trials Unit are eligible to participate.
Date of first enrolment08/04/2015
Date of final enrolment20/04/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Trials Unit
Bristol Dental School and Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom

Sponsor information

The Procter and Gamble Company
Industry

Procter & Gamble Technical Centres Limited
Rusham Park
Whitehall Lane
Egham, Surrey
TW20 9NW
United Kingdom

ROR logo "ROR" https://ror.org/02a8cv967

Funders

Funder type

Industry

Procter and Gamble
Government organisation / For-profit companies (industry)
Alternative name(s)
Procter & Gamble, PandG, The Procter & Gamble Company, P&G
Location
United States of America

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWithin a year of the study conclusion, it is anticipated that the study will be submitted for publishing in a peer reviewed journal and the results presented at an international conference.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2018 Yes No
Protocol file version 1 09/02/2017 24/10/2022 No No
HRA research summary 28/06/2023 No No
Results article erosion protection efficacy 17/12/2018 08/07/2024 Yes No

Additional files

30557 Protocol V1 09Feb17.pdf

Editorial Notes

08/07/2024: Publication reference and total final enrolment added.
24/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
11/02/2019: Publication reference added.
14/09/2017: No publications found, verifying study status with principal investigator.