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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult male or female ≥ 18 years (18th birthday completed)

• Affiliation to a social welfare system

• Signed informed consent form

• More than 12 natural teeth suitable for evaluation

• Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria

Locations
Other Locations
France
Service de parodontologie
RECRUITING
Strasbourg
Contact Information
Primary
Sophie JUNG
sophie.jung1@chru-strasbourg.fr
00333.88.11.69.56
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Arm 1: Manual toothbrush
Experimental: Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)
Experimental: Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)
Experimental: Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov