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

Study Overview
=================
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.

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

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)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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