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

NCT05375227 | Unknown

• 1 other identifier: 2020-A02614-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the gingival abrasion (GA): Macro-relief scoring

  A first method for the evaluation of gingival abrasion (GA) will consist in a method of macro-relief scoring of gingival tissue as described previously by Perin et al. with skin tissue. This evaluation consists of acquiring macroscopic views of each investigated surface and then classifying them by observers according to a reference groups of defined abrasion intensity. This evaluation scoring, using photo grading technique, allow delayed and blinded scoring, independent of whole-subject appearance, thus decreasing subjectivity (Perin et al., 2000). Five items are evaluted for each picture : erythema, inflammation, bleeding, recession and erosion of the gingiva. All items are scored from 0 to 3, 3 representing the most significant impairment.

  90 days

Secondary Outcomes (5)

• Comparison of gingival color;

  90 days

• Presence of plaque -Plaque index, PI

  90 days

• Presence of inflammation BOP

  90 days

• Presence and/or amount of gingival recession (REC)

  90 days

• Probing pocket depth (PD)

  90 days

Study Arms (2)

Electric Toothbrush

EXPERIMENTAL

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

Other: Teeth brushing

Manual toothbrush

ACTIVE COMPARATOR

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

Other: Teeth brushing

Interventions

Teeth brushing 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

Electric Toothbrush; Manual toothbrush

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dentate males and females must be at least 18 years and not more than 75 years of age
• Patient able to understand and sign the informed consent prior to starting the study
• Patient with a minimum of 3 teeth in each of the 4 quadrants and no/or pockets \>4 mm
• Ability and willingness to comply with all study requirements.

You may not qualify if:

• Pregnancy
• Patient with cervical restorations
• Current smoker
• Patient with orthodontic banding
• Patient with oral lesions or periodontal diseases
• Patient who has been deprived of his/her freedom by administrative or legal decision or who is under trusteeship/guardianship
• Patient already using an electric toothbrush
• 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;
• Patient with non-plaque induced gingival diseases or localized gingival ulceration
• Thin gingival phenotype
• Patients with cardiac pacemakers to prevent any interference between the power toothbrush and the implantable cardiac device.

Sponsors & Collaborators

• Philips France Commercial: lead

Study Sites (1)

Rothschild Hospital

Paris, France

Location

Study Officials

• Philippe BOUCHARD, Pr Dr

  Rothschild Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Watts, Dr

CONTACT

+33 (0)1 47 28 10 00; marc.watts@philips.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: May 16, 2022
• Study Start: July 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)