Mouth Handicap in Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2022-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patients Diagnosed With Scleroderma and Their Chewing and Swallowing Performance

NCT07182981

Systemic Sclerosis (SSc) Scleroderma Scleroderma (Limited and Diffuse) +2 more

RECRUITING

Patients Diagnosed With Scleroderma: Physical Performance and Functionality

NCT07183072

Systemic Sclerosis (SSc) Scleroderma Scleroderma (Limited and Diffuse) +2 more

RECRUITING

Oral Manifestations of Systemic Sclerosis

NCT02371005

Scleroderma, Systemic

TERMINATED NA

Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma

NCT07326033

Systemic Scleroderma

NOT_YET_RECRUITING PHASE2

Oral Health and People With Systemic Sclerosis

NCT01817361

Systemic Sclerosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Systemic Sclerosis is an autoimmune connective tissue disease with fibrosis. Although its etiology and pathogenesis have not been clearly defined, it has a chronic course. Systemic sclerosis is estimated to affect approximately 300,000 people in the United States. Most commonly, it affects adults and women.

Narrowing of the mouth opening and mouth pain are the two most important causes reported by adults with systemic sclerosis. In patients with systemic sclerosis, orofacial findings such as microstomy or reduced mouth opening are frequently seen. Microstomy is defined as the distance between the incisors is less than 40 millimeters. In severe microstomy, this distance is less than 30 millimeters. It is approximately 33 millimeters in adults with systemic sclerosis. Microstomy in systemic sclerosis mainly results from submucosal collagen deposits that contribute to fibrosis in the perioral tissue. Microstomy is seen in 43% to 80% of adults with systemic sclerosis.

When the current literature is examined, Bongi et al. evaluated the effectiveness of face-specific programs, which are applied together with general rehabilitation programs in patients with systemic sclerosis; they demonstrated that these techniques improve disability, health-related quality of life (HRQoL), and facial functionality.

In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scleroderma Systemic Sclerosis Mouth Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Evaluation

Cases will be evaluated for oral health and data will be recorded.

Group Type EXPERIMENTAL

Evaluation

Intervention Type OTHER

The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation

The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* To be diagnosed with systemic sclerosis
* Stability of medical treatments
* Turkish literacy

Exclusion Criteria

* The patient has a history of neurological disease or trauma that may affect his symptoms
* Oral treatment for the last 6 months
* Being in active phase of the disease
* Skin infection and presence of open wound
* Having used dental orthosis in the last month
* Disorder of cognition or cooperation

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No