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

NCT04627857 | Recruiting

• 1 other identifier: 8014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changing of plaque index between baseline, week 2 and week 4

  day 0, week 2 and week 4

Study Arms (4)

Arm 1: Manual toothbrush

ACTIVE COMPARATOR

Device: Manual toothbrush

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

EXPERIMENTAL

Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss)

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

EXPERIMENTAL

Device: Sonic toothbrush

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

EXPERIMENTAL

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

Interventions

Manual toothbrush 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 1: Manual toothbrush

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de parodontologie

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Sophie JUNG

CONTACT

00333.88.11.69.56; sophie.jung1@chru-strasbourg.fr

Study Design

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

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: July 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)