Efficacy of an Automatic Toothbrush

NCT ID: NCT05594134

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2022-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Plaque

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Automatic toothbrush with nylon bristles

Group Type EXPERIMENTAL

Automatic toothbrush with nylon bristle

Intervention Type OTHER

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

Automatic toothbrush with silicone bristles

Group Type ACTIVE_COMPARATOR

Automatic toothbrush with silicone bristle

Intervention Type OTHER

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

Manual toothbrush used for 2 minutes

Group Type ACTIVE_COMPARATOR

Manual toothbrush used for 2 minutes

Intervention Type OTHER

A conventional manual toothbrush will be used for 2 minutes

Manual toothbrush used for 45 seconds

Group Type ACTIVE_COMPARATOR

Manual toothbrush used for 45 seconds

Intervention Type OTHER

A conventional manual toothbrush will be used for 45 seconds

No brushing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Automatic toothbrush with nylon bristle

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

Intervention Type OTHER

Automatic toothbrush with silicone bristle

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

Intervention Type OTHER

Manual toothbrush used for 2 minutes

A conventional manual toothbrush will be used for 2 minutes

Intervention Type OTHER

Manual toothbrush used for 45 seconds

A conventional manual toothbrush will be used for 45 seconds

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florence

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lorenzo Franchi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dentistry, The University of Florence

Florence, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IUFET2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.