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

NCT ID: NCT04627857

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-03-01

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.

Conditions

Scleroderma Systemic

Study Design

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

Study Groups

Arm 1: Manual toothbrush

Group Type: ACTIVE_COMPARATOR

Manual toothbrush

Intervention Type: DEVICE

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.

Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)

Group Type: EXPERIMENTAL

Manual toothbrush and water flosser (Philips Sonicare AirFloss)

Intervention Type: DEVICE

\- 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.

Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)

Group Type: EXPERIMENTAL

Sonic toothbrush

Intervention Type: DEVICE

\- 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.

Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

\- 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de parodontologie

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sophie JUNG

Role: CONTACT

sophie.jung1@chru-strasbourg.fr

00333.88.11.69.56

Facility Contacts

Sophie JUNG

Role: primary

Other Identifiers

8014

Identifier Type: -

Identifier Source: org_study_id