A clinical study to compare the dental plaque removal efficacy of a new electric toothbrush compared to a regular manual toothbrush

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: The computer‐generated randomization of the test products is created in cooperation with a statistician (Dr Julie Grender) from P&G. Participants are randomly allocated to a treatment sequence of the two toothbrushes. Participants brush for 8 days per study period at home twice daily (morning and evening) for 2 min according to the manufacturer’s use instructions with their assigned toothbrush: two periods with the electric brush, two periods with the manual brush (four periods in total, each period consists of 8 days). Participants brush the whole time with standard anti‐cavity toothpaste. Participants will be requested to use exclusively their assigned products at home for the duration of each study period. Each treatment period of this cross‐over study will be 8 days in duration (Tuesday through Tuesday) and will consist of Day 1, Day 3 and Day 8 study visits. Each study visit will consist of a pre‐brushing DPIA measurement followed by a supervised on‐site product use (this brushing will be considered one of the two daily brushings) and a second DPIA measurement taken approximately 5 hours post‐brushing. There will be 6 days of washout between treatment periods (Wednesday through Monday) during which participants will use a manual toothbrush and NaF toothpaste as acclimation product. This study procedures will be repeated until participants have completed four treatment periods using their randomly assigned treatment sequence. The plaque is assessed using a digital photo of the front teeth after staining with fluorescein. The test person places her/his chin in a chin rest and uses two plastic retractors to open the oral cavity sufficiently so that the entire front tooth area is clearly visible. The upper and lower in CONDITION: Dental caries prevention ; Oral Health ; Dental caries PRIMARY OUTCOME: Differences in afternoon plaque (5 hours post‐brushing) measured by DPIA score (digital plaque imaging analysis) across the 8 days of treatment SECONDARY OUTCOME: Morning pre‐brushing plaque coverage measured by DPIA score (digital plaque imaging analysis) analysed separately for days 3 and 8 to determine treatment differences INCLUSION CRITERIA: 1. Be at least 18 years of age 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 sufficient amount of plaque (estimated 10% coverage on buccal sites of front teeth after 24 hours build‐up as estimated by DPIA operator) 5. Possess a minimum of 10 natural anterior teeth with facial scorable surfaces (Not including teeth with crowns, excessive facial restorations or severe staining from tetracycline, fluorosis or hypocalcification) 6. Agree not to participate in any other oral care study for the duration of this study 7. Agree to return for scheduled visits and follow the study procedures 8. Agree to refrain from use of any non
Epistemonikos ID: fe01b20edc7f4203b8f57308c47f2450228c9711
First added on: Aug 24, 2024