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

NCT ID: NCT04336475

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Microstomia; Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

exercise regimen and oral hygiene care advices

Group Type: EXPERIMENTAL

orofacial exercise program

Intervention Type: OTHER

combined stretching\&strengthening exercise regimen

Group 2

oral hygiene care advices

Group Type: ACTIVE_COMPARATOR

orofacial exercise program

Intervention Type: OTHER

combined stretching\&strengthening exercise regimen

Interventions

orofacial exercise program

combined stretching\&strengthening exercise regimen

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Nihan Cüzdan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nihan Cuzdan, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Cukurova University

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Cukurova University Nihan C.

Identifier Type: -

Identifier Source: org_study_id