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

NCT04336475 | Completed Results

• 1 other identifier: Cukurova University Nihan C.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Microstomia; Systemic Sclerosis

Keywords

exercise; microstomia; oral aperture; rehabilitation; systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Oral Aperture Measurement

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

  2 months

Study Arms (2)

Group 1

EXPERIMENTAL

exercise regimen and oral hygiene care advices

Other: orofacial exercise program

Group 2

ACTIVE COMPARATOR

oral hygiene care advices

Other: orofacial exercise program

Interventions

orofacial exercise program OTHER

combined stretching\&strengthening exercise regimen

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \* systemic sclerosis patients with an interincisal distance of \<40 mm

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Microstomia; Scleroderma, Systemic; Motor Activity

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior

Results Point of Contact

• Title: Dr Nihan Cuzdan, MD, principal investigator
• Organization: Cukurova University

nihancuzdan@hotmail.com

05052706846

Study Officials

• Nihan Cuzdan, MD

  MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: March 1, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: April 29, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: up to 6 months
• Access Criteria: researchers who are willing to access to individual participant data will be reviewed and approved by the principal investigator.

Locations

TU (1)