A randomized clinical study to compare the efficacy of a new interactive toothbrush in the prevention of dental stain
| ISRCTN | ISRCTN80868903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80868903 |
| Secondary identifying numbers | Clinical Protocol 2020137 |
- Submission date
- 30/04/2021
- Registration date
- 04/05/2021
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Tooth appearance can be dramatically impacted by extrinsic dental stains. Extrinsic dental stains are discolorations that accumulate on the external surface of the tooth and can be removed by toothbrushing, scaling, and/or polishing. Manual and electric toothbrushes have the potential to remove the surface dental stain by mechanical action. The aim of this study is to evaluate and compare the effectiveness of a new interactive electric toothbrush with a whitening brush head to a marketed regular manual toothbrush in the prevention of dental stain over a 12-week period.
Who can participate?
Generally healthy adults with evidence of dental stain on the anterior teeth.
What does the study involve?
Participants will be randomly assigned to either the test group (a new interactive electric toothbrush with a whitening brush head) or the control group (a regular manual toothbrush). Participants will use their assigned toothbrush with a regular toothpaste twice daily at home for the duration of the study in place of their regular toothbrush and toothpaste. Toothbrushes will be returned at the end of the study. The study is designed to assess if the participants in the test group experience an improvement in the prevention of dental stain. Dental stain measurements will be taken at the first visit, week 4, and week 12 visits. At the first visit, participants will receive a partial prophylaxis on the anterior teeth to remove all surface stains.
What are the possible benefits and risks of participating?
Participation will help with the development of products that aim to improve oral health. There will be no notable risks involved with participating. This study involves the use of toothbrushes as part of a normal oral hygiene routine. No behavior with increased risk will be requested from participants. The toothpaste provided in this study is currently marketed. The risk from chemical hazard is negligible, or no greater than what would be encountered during daily life. Also, both kinds of toothbrushes are currently marketed. Toothbrushes are not anticipated to cause any serious or long-term effects on oral tissue including gum recession.
Where is the study run from?
All Sum Research Ltd (Canada)
When is the study starting and how long is it expected to run for?
February 2021 to October 2021
Who is funding the study?
Procter and Gamble Company (USA)
Who is the main contact?
Dr Chhaju Ram Goyal, DDS
crgoyal@allsumrc.com
Contact information
Scientific
6635 Kitimat Rd. #36 & #37
Mississauga, Ontario
L5N 6J2
Canada
| Phone | +1 (0)905 812 1099 |
|---|---|
| crgoyal@allsumrc.com |
Study information
| Study design | Single-center randomized controlled examiner-blind two-treatment parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A clinical study to compare the stain prevention potential of a new power brush with a whitening brush head compared to a manual control toothbrush |
| Study objectives | The objective of this study is to assess the dental stain prevention potential of a new power toothbrush with a whitening brush head compared to a regular manual toothbrush. |
| Ethics approval(s) | Approved 21/04/2021, Veritas IRB Inc. (8555 Transcanada Hwy., Suite 201, Montreal, Quebec, H4S 1Z6, Canada; +1 (0)514 337 0442; nhamzeh@veritasirb.com), ref: 2021-2679-5886-1 |
| Health condition(s) or problem(s) studied | Dental stain on facial surfaces of the anterior teeth |
| Intervention | Participants are stratified at baseline on average modified Lobene composite score of the facial and lingual surfaces, smoking, the consumption of coffee/tea and age. Within these strata, participants are randomly assigned to either the test group (new interactive toothbrush with whitening brush head) or the control group (marketed regular manual toothbrush). Participants are instructed to use the study products according to the manufacturer instructions (electric toothbrush) or in their customary manner (manual toothbrush) at home twice daily (morning and evening) in place of their normal oral hygiene for the duration of the study (12 weeks). Dental stain measurements are taken at baseline, week 4, and week 12 visits. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | 1. Intensity and extent of extrinsic dental stain on the facial and lingual surfaces of the anterior teeth is measured using Composite Modified Lobene Stain Index at Week 4 and Week 12 2. Intensity and extent of extrinsic dental stain in four different regions (gingival, body, mesial and distal) on the facial surfaces of the anterior teeth is measured using Interproximal Modified Lobene Index at Weeks 4 and 12 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/02/2021 |
| Completion date | 07/10/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Be at least 18 years of age and typically use a manual toothbrush 2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form 3. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history 4. Have a minimum of 10 anterior teeth suitable for grading (i.e., no crowns, bridge abutments, composites or porcelain veneers, large composite restorations or anterior calculus) with visible surface stain on the facial surfaces 5. Agree not to participate in any other oral care study for the duration of this study 6. Agree to return for scheduled visits and follow the study procedures 7. Agree to refrain from the use of any non-study oral hygiene products (including prescription rinses) for the duration of the study 8. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study and to report any non-study dentistry received during the course of this study |
| Key exclusion criteria | 1. Generalized gingival recession 2. Generalized malocclusion or overlapping of teeth 3. Inability to comply with brushing instructions (e.g. dexterity or comprehension issues) 4. Obvious periodontal disease, as evidenced by purulent exudate, tooth mobility, or any condition that could potentially compromise the integrity of the data 5. Fixed orthodontic appliances on the facial surfaces of their anterior teeth 6. Self-reported pregnancy or lactation 7. Severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis, or hypo-calcification on the facial surface of their anterior teeth 8. Carious lesions on the facial surface of their anterior teeth 9. Had a dental prophylaxis within the previous 2 months 10. Have any condition or disease, as determined by the Investigator/Designee, which could be expected to interfere with study procedures or with the subject’s safe completion of the study |
| Date of first enrolment | 28/06/2021 |
| Date of final enrolment | 05/07/2021 |
Locations
Countries of recruitment
- Canada
Study participating centre
Mississauga, Ontario
L5N 6J2
Canada
Sponsor information
Industry
8700 Mason-Montgomery Road
Mason
45040
United States of America
| Phone | +1 (0)513 622 1000 |
|---|---|
| erb.j@pg.com | |
| Website | http://www.pg.com/en_US/ |
"ROR" |
https://ror.org/04dkns738 |
Funders
Funder type
Industry
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 date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol, statistical analysis plan, and other additional documents are not intended to become available online. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because if the raw data is available but not analyzed appropriately by qualified experts in the area, it may lead to misinterpretation of the results. |
Editorial Notes
11/06/2025: Sponsor details updated.
16/11/2022: The intention to publish date was changed from 31/03/2022 to 01/04/2023.
29/09/2022: The overall end date was changed from 15/10/2021 to 07/10/2021.
19/07/2021: The total final enrolment was added.
15/06/2021: The following changes have been made:
1. The recruitment start date has been changed from 21/06/2021 to 28/06/2021.
2. The recruitment end date has been changed from 28/06/2021 to 05/07/2021.
04/05/2021: Trial's existence confirmed by Veritas IRB.
