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

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.

Study Overview

• Status: Recruiting
• Conditions: Scleroderma Systemic
• Intervention / Treatment: Device: Manual toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Sonic toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie JUNG; Phone Number: 00333.88.11.69.56; Email: sophie.jung1@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • Service de parodontologie
    • Contact: Sophie JUNG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Manual toothbrush	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.
Experimental: Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)	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.
Experimental: Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)	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.
Experimental: Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changing of plaque index between baseline, week 2 and week 4	day 0, week 2 and week 4

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 8014 (NCI/CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No