A clinical study to assess the efficacy of an electric toothbrush with two different mode settings to reduce dental plaque and gingival inflammation
| ISRCTN | ISRCTN61582326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61582326 |
| Secondary identifying numbers | 2023041 |
- Submission date
- 14/07/2023
- Registration date
- 17/07/2023
- Last edited
- 25/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gingivitis is a common and mild form of gum inflammation that commonly occurs because plaque accumulates on the teeth. It can be prevented and treated with good oral hygiene. Toothbrushes are continuously tested for their effectiveness and safety as new devices or improvements of features on existing devices are developed. The aim of this study is to evaluate and compare the efficacy of two different frequency settings for a new experimental power brush to a regular manual brush in the reduction of gingivitis and dental plaque over an up to 4-week period.
Who can participate?
Generally healthy adults with evidence of plaque and mild to moderate gingivitis.
What does the study involve?
Participants will be randomly assigned to either the test group #1 (electric toothbrush with 100Hz operating mode), test group #2 (electric toothbrush with 85Hz operating mode) or the Control group (regular manual toothbrush). Participants will use their assigned toothbrush with a regular toothpaste twice daily at home for the duration of the assignment. Toothbrushes will be returned at the end of the study.
The study is designed to assess if the participants in the two test groups experience an improvement in oral health in comparison to the Control.
Plaque and gingivitis measurements will be taken at baseline, week 1, and week 4 visits.
The individual appointments will be scheduled for about the same time for all visits. Participants will be instructed to abstain from any oral hygiene for 12 hours before all visits.
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 have been encountered during daily life. The experimental electrical toothbrush is made from materials used in currently marketed brushes and the Control regular manual toothbrush is currently marketed. There are no anticipated risks from the materials used in the experimental toothbrush. Also, 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?
June 2023 to October 2023
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
Principal Investigator
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 examiner-blind 4-week 3-treatment parallel-group randomized 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 4-week clinical study to compare a new electrical toothbrush used with two different frequency settings to a manual control toothbrush in the reduction of gingivitis and plaque |
| Study objectives | The objective of the study is to evaluate and compare the efficacy of a new experimental electric toothbrush with two different frequency settings to a regular manual toothbrush in the reduction of gingivitis and dental plaque over a 4-week period by using the Modified Gingival Index, the Gingival Bleeding Index and the Rustogi Modification of the Navy Plaque Index. |
| Ethics approval(s) |
Approved 12/07/2023, Veritas IRB Inc. (3551 St. Charles Blvd., Suite 501, Kirkland, Quebec, H9H 3C4, Canada; +1 (0)514 337 0442; infoirb@veritasirb.com), ref: 2023-3305-15178-5 |
| Health condition(s) or problem(s) studied | Evidence of dental plaque and gingivitis |
| Intervention | Participants are stratified at baseline on mean gingivitis score, number of bleeding sites, mean plaque index and tobacco use. Within these strata, participants are randomly assigned to one of the three treatment groups (experimental electric toothbrush operating with either 100Hz or 85Hz or a regular Control manual toothbrush). The randomization will be done using a computer-based program which is provided by the sponsor. Participants are instructed to use the study products according to the manufacturer's instructions (electric toothbrush groups) or in their customary manner (manual brush group) at home twice daily (morning and evening) in place of their normal oral hygiene for the duration of the study (4 weeks). All products will be used with a regularly marketed dentifrice. Plaque and gingivitis measurements will be taken at Baseline, Week 1, and Week 4 visits. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oral-B iO2 |
| Primary outcome measure | Whole mouth plaque change from Baseline at Week 4 measured by the Rustogi Modification of the Navy Plaque Index (RMNPI). |
| Secondary outcome measures | 1. Number of bleeding sites change from Baseline at Week 4 measured by visual examination 2. Gingivitis change from Baseline at Week 4 measured by the Gingival Bleeding Index and the Modified Gingival Index. |
| Overall study start date | 01/06/2023 |
| Completion date | 13/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Give written informed consent prior to study participation and be given a signed copy of their informed consent form 2. Be at least 18 years of age and mainly use a manual toothbrush; 3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history; 4. Possess a minimum of 16 natural teeth with facial and lingual scorable surfaces; 5. Have localized or generalized gingivitis with a range of 10% to 70% bleeding sites (sites with a score of 1 or 2 on the GBI index) for Baseline exam); 6. Have a whole mouth mean MGI score between 1.75 and 2.5 for Baseline exam; 7. Have a whole mouth RMNPI score of greater than 0.5 for Baseline exam; 8. Agree not to participate in any other oral care study for the duration of this study; 9. Agree to not to have any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received at any time during the course of this study; 10. Agree to refrain from using any non-study oral hygiene products for the study duration; 11. Agree to return for all their scheduled visits and to follow all study procedures; 12. Refrain from brushing their teeth or from performing any other oral hygiene procedure anytime within the 12 hours prior to Baseline Visit and agree to follow these same restrictions prior to all visits; 13. Refrain from medicated lozenges, breath mints, eating, drinking*, chewing gum and using tobacco (of any kind) for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *(Allowed small sips of water up until 45 minutes prior to their appointments.) |
| Key exclusion criteria | 1. A condition requiring the need for antibiotic premedication prior to dental procedures; 2. Severe periodontal disease, including but not limited to, purulent exudates, generalized mobility, and/or severe recession; 3. Any carious lesions requiring restorative treatment; 4. Active treatment for the following conditions: periodontitis, cancer, or a seizure disorder; 5. Taking an antibiotic or using a chlorhexidine mouth rinse any time within the previous 2 weeks; 6. Having a dental prophylaxis any time within the previous 4 weeks; 7. Suffer from diabetes; 8. Taking anti-inflammatory or anti-coagulant medications any time within the previous 2 weeks; 9. Have any of the following: orthodontic appliances, removable partial dentures, peri/oral piercings, a pacemaker or other implanted device; 10. Oral/gum surgery within the previous two months; 11. A disease or condition that could possibly interfere with examination/procedures or with the subject’s safe completion of this study (including allergies to dye). |
| Date of first enrolment | 15/09/2023 |
| Date of final enrolment | 20/10/2023 |
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 | 31/12/2024 |
|---|---|
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/06/2025 | 25/06/2025 | Yes | No |
Editorial Notes
25/05/2025: Publication reference added.
11/06/2025: Sponsor details updated.
07/11/2024: The following changes were made to the trial record:
1. The overall end date was changed from 20/10/2023 to 13/10/2023.
2. The total final enrolment was added.
14/08/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 31/07/2023 to 15/09/2023.
2. The recruitment end date was changed from 15/08/2023 to 20/10/2023.
3. The overall end date was changed from 29/09/2023 to 20/10/2023.
14/07/2023: Trial's existence confirmed by Veritas IRB.
