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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis; Microstomia
• Intervention / Treatment: Other: orofacial exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01030
    • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; exercise regimen and oral hygiene care advices	Other: orofacial exercise program; combined stretching&strengthening exercise regimen
Active Comparator: Group 2; oral hygiene care advices	Other: orofacial exercise program; combined stretching&strengthening exercise regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Oral Aperture Measurement	the interincisal distance between the maxillary and mandibular central incisors in the midline	2 months

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Nihan Cuzdan, MD, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; systemic sclerosis; microstomia; oral aperture
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Congenital Abnormalities; Connective Tissue Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Microstomia
• Other Study ID Numbers: Cukurova University Nihan C.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all collected IPD may be shared with other researches.
• IPD Sharing Time Frame: up to 6 months
• IPD Sharing Access Criteria: researchers who are willing to access to individual participant data will be reviewed and approved by the principal investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No