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

Scleroderma Systemic Clinical Trial

— ScleroBross  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627857
• Other study ID #: 8014
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Sophie JUNG
• Phone: 00333.88.11.69.56
• Email: sophie.jung1[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma Systemic
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Service de parodontologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing of plaque index between baseline, week 2 and week 4		day 0, week 2 and week 4