The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients

Systemic sclerosis is a systemic disease which may involve multiple organ systems and cause functional disabilities. Microstomia is one of the most common complications of the disease which may result in difficulties performing oral self-care, complication in professional dental care and even malnutrition in the advanced cases. Since the disease is rare and the studies are limited, there is still not an agreed upon orofacial exercise program to improve the oral aperture of the patients. Therefore, we aimed to investigate the effect of a newly diseased home-based exercise program for improving microstomia in those patient population.

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Key information

Conditions

Microstomia Behavior Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Motor Activity Mouth Abnormalities Mouth Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Systemic Sclerosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, 01030, Turkey (Türkiye)

About this study

The study was designed as a single-blind, prospective, randomized controlled study with a 2-month follow-up period, carried out in rheumatology outpatient clinic, between March 2017 - January 2019. Systemic sclerosis patients with an oral aperture of <40mm were included in the study. Patients were randomly divided into two groups. Randomization was done as the sealed envelope method. After the informed consent was taken, the opaque envelope that the patient have chosen was opened and patients were offered the allocated treatment regimen. Group 1 was given exercise regimen and oral hygiene care advices for the first one month; followed by no exercise but oral hygiene care advices for the next four weeks. Group 2, as the control group, received oral hygiene care advices for the first one month, followed by the exercise regimen twice a day along with oral hygiene care advices for the next four weeks. Oral care advices were given to every participant by a dentist involved in the study at their first visit. With this protocol, we aimed (a) to investigate whether there is a benefit of the exercise program on microstomia; (b) to observe the carryover effect of exercise therapy on microstomia after discontinuing the treatment over a period of time; (c) to estimate the intervention strategy by comparing the same medical approach with different sequences. The exercise program was demonstrated to patients by a clinician at the first visit and given to all patients printed as a manual to be done every day for one month duration of the exercise program. Additionally, a diary was given to patients to mark when they have completed the exercise and to note in the case of pain on daily basis. The exercise regimen was developed on the basis of previous studies and clinical knowledge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

systemic sclerosis patients with an interincisal distance of <40 mm

Exclusion criteria

patients with missing teeth
dysfunction of temporo-mandibular joints
oral malignancy
recent dental procedures
multiple active digital ulcers
diagnosed psychiatric conditions

Treatment and study plan

orofacial exercise program

Other

combined stretching&strengthening exercise regimen

Primary outcomes

Change From Baseline in Oral Aperture Measurement

Time frame: 2 months

the interincisal distance between the maxillary and mandibular central incisors in the midline

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

The Effect of a Combined Home-based Orofacial Exercise Program on Oral Aperture of Patients With Systemic Sclerosis: a Single-blind Prospective Randomized Controlled Trial

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Apr 7, 2020
Registry last updated: Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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