Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue

NCT ID: NCT05375227

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-04-01

Brief Summary

This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.

Conditions

Gingival Abrasion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Electric Toothbrush

Electric toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL)

Group Type: EXPERIMENTAL

Teeth brushing

Intervention Type: OTHER

The participants will be invites to brush their teeth twice a day for 3 months using either an electric toothbrush or a mannual toothbrush and low abrasivity toothpaste

Manual toothbrush

Manual toothbrush + manufacturer's instructions + professional recommendations + sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL)

Group Type: ACTIVE_COMPARATOR

Teeth brushing

Intervention Type: OTHER

The participants will be invites to brush their teeth twice a day for 3 months using either an electric toothbrush or a mannual toothbrush and low abrasivity toothpaste

Interventions

Teeth brushing

The participants will be invites to brush their teeth twice a day for 3 months using either an electric toothbrush or a mannual toothbrush and low abrasivity toothpaste

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Dentate males and females must be at least 18 years and not more than 75 years of age

2. Patient able to understand and sign the informed consent prior to starting the study

3. Patient with a minimum of 3 teeth in each of the 4 quadrants and no/or pockets >4 mm

4. Ability and willingness to comply with all study requirements.

Exclusion Criteria

1. Pregnancy

2. Patient with cervical restorations

3. Current smoker

4. Patient with orthodontic banding

5. Patient with oral lesions or periodontal diseases

6. Patient who has been deprived of his/her freedom by administrative or legal decision or who is under trusteeship/guardianship

7. Patient already using an electric toothbrush

8. Patient with conditions or circumstances, which may prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability;

9. Patient with non-plaque induced gingival diseases or localized gingival ulceration

10. Thin gingival phenotype

11. Patients with cardiac pacemakers to prevent any interference between the power toothbrush and the implantable cardiac device.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips France Commercial

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe BOUCHARD, Pr Dr

Role: PRINCIPAL_INVESTIGATOR

Rothschild Hospital

Locations

Rothschild Hospital

Paris, , France

Countries

France

Central Contacts

Marc Watts, Dr

Role: CONTACT

marc.watts@philips.com

+33 (0)1 47 28 10 00

Facility Contacts

Philippe BOUCHARD, Pr Dr

Role: primary

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020-A02614-35

Identifier Type: -

Identifier Source: org_study_id