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 range18 Years

SexFEMALE

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.

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