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

• Sponsor: Cukurova University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04336475
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microstomia; Systemic Sclerosis	Other: orofacial exercise program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Oral Aperture Measurement [2 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana		Turkey	01030

Sponsors and Collaborators

• Cukurova University

Investigators

• Principal Investigator: Nihan Cuzdan, MD, MD

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 10, 2016
• Informed Consent Form - Jun 10, 2016

More Information

Publications

None provided.

• Responsible Party: Nihan Cüzdan, Principal Investigator, Cukurova University
• ClinicalTrials.gov Identifier: NCT04336475
• Other Study ID Numbers: Cukurova University Nihan C.
• First Posted: Apr 7, 2020
• Last Update Posted: Apr 29, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nihan Cüzdan, Principal Investigator, Cukurova University: exercise; microstomia; oral aperture; rehabilitation; systemic sclerosis
• Additional relevant MeSH terms: Microstomia; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis

Study Results

Participant Flow

Recruitment Details	Participants were recruited based on randomization in outpatient rheumatology clinic. First patient was enrolled on March 2017 and the last participant was enrolled in October 2018.
Pre-assignment Detail	156 patients were evaluated and 74 met inclusion criteria. 14 patients refused to participate. 60 patients were randomized.

Arm/Group Title	Exercise + Oral Hygiene First, Then Oral Hygiene Only	Oral Hygiene Only First, Then Exercise + Oral Hygiene
Arm/Group Description	Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.	patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.
Period Title: Overall Study
STARTED	30	30
COMPLETED	28	28
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Exercise + Oral Hygiene First, Then Oral Hygiene Only	Oral Hygiene Only First, Then Exercise + Oral Hygiene	Total
Arm/Group Description	Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.	Patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right & left molars. 5.The subject pushes the chin to left and right sides.	Total of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	22 78.6%	24 85.7%	46 82.1%
>=65 years	6 21.4%	4 14.3%	10 17.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.82 (9.63)	50.0 (11.4)	52 (11.0)
Sex: Female, Male (Count of Participants)
Female	27 96.4%	26 92.9%	53 94.6%
Male	1 3.6%	2 7.1%	3 5.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	28 100%	28 100%	56 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	28 100%	28 100%	56 100%
oral aperture (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	31.17 (4.90)	33.05 (5.53)	32.11 (5.26)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise + Oral Hygiene First, Then Oral Hygiene Only	Oral Hygiene Only First, Then Exercise + Oral Hygiene
Arm/Group Description	st month > exercise + oral hygiene nd month> oral hygiene only	st month> Oral Hygiene Only nd month > exercise + oral hygiene
Measure Participants	28	28
1 st month	32.98 (5.01)	32.92 (6.13)
2 nd month	33.40 (5.33)	34.37 (6.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise + Oral Hygiene First, Then Oral Hygiene Only, Oral Hygiene Only First, Then Exercise + Oral Hygiene
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.564
	Comments	The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)
	Method	ANOVA
	Comments	Repeated Measures ANOVA

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	since this is not a drug study mortality and serious adverse events are not expected.
Arm/Group Title	Exercise + Oral Hygiene		Oral Hygiene Only
Arm/Group Description	Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care.		Patients only perform daily oral hygiene care advices
All Cause Mortality
	Exercise + Oral Hygiene		Oral Hygiene Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Serious Adverse Events
	Exercise + Oral Hygiene		Oral Hygiene Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Exercise + Oral Hygiene		Oral Hygiene Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/56 (1.8%)		0/56 (0%)
Musculoskeletal and connective tissue disorders
pain	1/56 (1.8%)	1	0/56 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.