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

Not Applicable

Recruiting

• Conditions: Scleroderma Systemic
• Interventions: Device: Sonic toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss); Device: Manual toothbrush

• Registration Number: NCT04627857
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-13
• Study Start: 2021-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)
• Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)
• Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
• Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
• Current use of sonic toothbrush and/or dental water flosser
• Severe manual handicap preventing the patient from holding a toothbrush with a large handle
• Oral antiseptics (e.g. chlorhexidin mouthwashes)
• Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
• Smoking (≥ 10 cigarettes per day)
• Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
• Individual under guardianship, curatorship or judicial protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)	Sonic toothbrush	-
Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)	Manual toothbrush and water flosser (Philips Sonicare AirFloss)	-
Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser	Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)	-
Arm 1: Manual toothbrush	Manual toothbrush	-

Primary Outcome Measures

Name	Time	Method
Changing of plaque index between baseline, week 2 and week 4	day 0, week 2 and week 4

Trial Locations

Locations (1)

Service de parodontologie; 🇫🇷 Strasbourg, France