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OpenTrials
Terminated

NCT Number: NCT04627857

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

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.

Why the study stopped: not enough patients
Terminated

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de parodontologie

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Changing of plaque index between baseline, week 2 and week 4

    Time frame: day 0, week 2 and week 4

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ScleroBross

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2020
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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