Efficacy of an Automatic Toothbrush

• Sponsor: University of Florence (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05594134
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 1.3
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

The objective of this study is to compare the efficacy in terms of bacterial plaque removal, in a single use, of a new Y-shaped automatic electric toothbrush with nylon bristles, compared with the electric toothbrush of similar shape but with silicone bristles, with the manual toothbrush, and with a negative control (no brushing) in a group of volunteer students.

Primary endpoint: difference in "full mouth plaque score" between before and after brushing.

Secondary endpoint: sensation of "clean mouth" assessed on VAS scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth.

Single-center, randomized, controlled, superiority, cross-over, examiner-blinded study with 5 treatments (Y-shaped electric toothbrush with nylon bristles, similarly shaped electric toothbrush with silicone bristles, manual brushing for 45 seconds, manual brushing for 2 minutes, no brushing), carried out in a single session and spaced one week apart.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Other: Automatic toothbrush with nylon bristle; Other: Automatic toothbrush with silicone bristle; Other: Manual toothbrush used for 2 minutes; Other: Manual toothbrush used for 45 seconds	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Efficacy of an Automatic Toothbrush With Nylon Bristles in Removing Dental Plaque: a Randomized Cross-over Study
• Anticipated Study Start Date: Nov 14, 2022
• Anticipated Primary Completion Date: Dec 23, 2022
• Anticipated Study Completion Date: Dec 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Automatic toothbrush with nylon bristles	Other: Automatic toothbrush with nylon bristle; The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch
Active Comparator: Automatic toothbrush with silicone bristles	Other: Automatic toothbrush with silicone bristle; The automatic toothbrush with silicone bristles will be used for 10 seconds
Active Comparator: Manual toothbrush used for 2 minutes	Other: Manual toothbrush used for 2 minutes; A conventional manual toothbrush will be used for 2 minutes
Active Comparator: Manual toothbrush used for 45 seconds	Other: Manual toothbrush used for 45 seconds; A conventional manual toothbrush will be used for 45 seconds
No Intervention: No brushing

Outcome Measures

Primary Outcome Measures

1. Change in full mouth plaque score [5 minutes]

   Difference in full mouth plaque score between before and after brushing

Secondary Outcome Measures

1. Perception of "clean mouth" [5 minutes]

   Sensation of "clean mouth" assessed on a visual analogue scale from 0 to 10 where 0 indicates no sensation of clean mouth and 10 maximum sensation of clean mouth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Absence of fixed orthodontic appliances

• Presence of at least 20 teeth

• Full mouth plaque score greater than 40%

• Having provided signed and dated informed consent.

Exclusion Criteria:

• Subjects with manual inability to perform normal oral hygiene maneuvers

• Subjects allergic to silicone or nylon.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dentistry, The University of Florence	Florence		Italy	50127

Sponsors and Collaborators

• University of Florence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lorenzo Franchi, Professor, University of Florence
• ClinicalTrials.gov Identifier: NCT05594134
• Other Study ID Numbers: IUFET2
• First Posted: Oct 26, 2022
• Last Update Posted: Oct 26, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Plaque

Study Results

No Results Posted as of Oct 26, 2022