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

Primary Purpose

Scleroderma Systemic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Manual toothbrush
Manual toothbrush and water flosser (Philips Sonicare AirFloss)
Sonic toothbrush
Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scleroderma Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de parodontologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm 1: Manual toothbrush

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

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

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 6, 2020
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT04627857
Brief Title
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Acronym
ScleroBross
Official Title
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma Systemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Manual toothbrush
Arm Type
Active Comparator
Arm Title
Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)
Arm Type
Experimental
Arm Title
Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)
Arm Type
Experimental
Arm Title
Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual toothbrush and water flosser (Philips Sonicare AirFloss)
Intervention Description
- 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.
Intervention Type
Device
Intervention Name(s)
Sonic toothbrush
Intervention Description
- 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.
Intervention Type
Device
Intervention Name(s)
Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)
Intervention Description
- 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 Outcome Measure Information:
Title
Changing of plaque index between baseline, week 2 and week 4
Time Frame
day 0, week 2 and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie JUNG
Phone
00333.88.11.69.56
Email
sophie.jung1@chru-strasbourg.fr
Facility Information:
Facility Name
Service de parodontologie
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie JUNG

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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