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RECRUITING
NCT04627857
NA

Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life. The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-07-01

Completion Date

2025-03-01

Last Updated

2024-08-19

Healthy Volunteers

No

Interventions

DEVICE

Manual toothbrush

Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.

DEVICE

Manual toothbrush and water flosser (Philips Sonicare AirFloss)

\- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.

DEVICE

Sonic toothbrush

\- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.

DEVICE

Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)

\- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.

Locations (1)

Service de parodontologie

Strasbourg, France