CompletedNot Applicable

A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis

39 participantsStarted 2013-02-01

Plain-language summary

Background: A typical feature of SSc is the fibrotic involvement of the connectival tissue of the face, which causes microstomia. Objectives: To test the effectiveness of an educational intervention with "face to face" training, compared to a standard information program, to reduce microstomia in women with SSc. Methods: SSc patients were randomized to the experimental and control group. Both groups received written and audiovisual information for self-management of microstomia; in addition, the experimental group received a reinforced training at baseline and at follow-up. Primary outcome: change in inter-incisal distance; secondary outcome: patient-reported mouth disability.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosis of SSc, according to the ACR/EULAR criteria; * age \>18 years; * ability to understand the Italian language; * subjective perception of problems with opening the mouth, such as hardened tissues, reduced mobility, pain - confirmed by a dermatologist; * signed informed consent. Exclusion Criteria: * edentulous patients, * presence of dental conditions, * documented dysfunction of the temporo-mandibular joint, * oral neoplasia, * sub-mandibular inflammatory conditions, * patients already undergoing face massages or face physiotherapy, * patients who had undergone mouth lipofilling, * patients with severe hand disability (including deep ulcers, and severe pain), * patients with documented psychiatric conditions or taking psychotropic medications.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Interincisal distance

Timeframe: 1 year

Trial details

NCT IDNCT03766243

SponsorIRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01-31

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