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Efficacy of an Automatic Toothbrush

NCT05594134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Dental Plaque

Interventions

OTHER

Automatic toothbrush with nylon bristle

The automatic toothbrush with nylon bristles will be used for 10 seconds per dental arch

OTHER

Automatic toothbrush with silicone bristle

The automatic toothbrush with silicone bristles will be used for 10 seconds

OTHER

Manual toothbrush used for 2 minutes

A conventional manual toothbrush will be used for 2 minutes

OTHER

Manual toothbrush used for 45 seconds

A conventional manual toothbrush will be used for 45 seconds

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2022-12-21
Completion
2022-12-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594134 on ClinicalTrials.gov