MicrostomiaNCT04336475
The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients
A study testing orofacial exercise program in people with Microstomia and Systemic Sclerosis, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microstomia, Systemic Sclerosis
- What is being tested?
- orofacial exercise program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- systemic sclerosis patients with an interincisal distance of <40 mm
Who cannot join
- patients with missing teeth
- dysfunction of temporo-mandibular joints
- oral malignancy
- recent dental procedures
- multiple active digital ulcers
- diagnosed psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- orofacial exercise program
- Keywords
- exercise, microstomia, oral aperture, rehabilitation, systemic sclerosis
- Medical subject headings
- Microstomia, Scleroderma, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orofacial exercise programOther
combined stretching\&strengthening exercise regimen
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | exercise regimen and oral hygiene care advices Receives: Other: orofacial exercise program |
| Group 2 | Active comparator | oral hygiene care advices Receives: Other: orofacial exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Oral Aperture Measurement
the interincisal distance between the maxillary and mandibular central incisors in the midline
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Mar 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MicrostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Cüzdan, Cukurova University
- Investigators
- Nihan Cuzdan, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336475
- Sponsor's protocol ID
- Cukurova University Nihan C.
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD may be shared with other researches.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04336475
- Acronym / sponsor ID
- Cukurova University Nihan C.
- Conditions
- Microstomia, Systemic Sclerosis
- Keywords
- exercise, microstomia, oral aperture, rehabilitation, systemic sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: orofacial exercise programexercise regimen and oral hygiene care advices |
| Group 2 | Active comparator | Other: orofacial exercise programoral hygiene care advices |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- systemic sclerosis patients with an interincisal distance of <40 mm
Key exclusion criteria (6 listed)
- patients with missing teeth
- dysfunction of temporo-mandibular joints
- oral malignancy
- recent dental procedures
- multiple active digital ulcers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orofacial exercise programcombined stretching\&strengthening exercise regimen | Other | Group 1, Group 2 |
Primary outcome
Change From Baseline in Oral Aperture Measurement
Time frame: 2 months
the interincisal distance between the maxillary and mandibular central incisors in the midline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. all collected IPD may be shared with other researches.
Related trials for Microstomia
Not yet recruitingPhase 2
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
Systemic Scleroderma
Recruiting
Efficacy of 3D-Printed Mouth Splints
Microstomia
Enrolling by invitation
Clinical Effectiveness of a Patient-tailored Orthosis Based on 3-dimensional (3D) Scanner Modeling and 3D Printing Technology for Microstomia Caused by Burns : Pilot Study
Burn, 3D Printing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihan Cuzdan, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orofacial exercise program in people with Microstomia and Systemic Sclerosis, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Oral Aperture Measurement (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.