Effectiveness of Two Oral Appliances for Managing Oral Self-biting Injuries in Patients With ALS

Study Overview
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Brief Summary
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This study assesses to determine the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. Thirty-one patients with amyotrophic lateral sclerosis will wear two devices, a hard occlusal splint (HOS) and a flexible customized mouthguard (FCM), for two weeks each one. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the HOS, and the other half wearing the FCM. The participants will rate the degree of satisfaction with the device and the degree of improvement or worsening of oral self-biting injuries in a 10-point scale. They will also rate the degree of change in their quality of life because of changes in their oral self-biting injuries. Finally they will rate the compliance and report the adverse effects.

Detailed Description
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This crossover intervention study aims to assess the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. Thirty-one patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital will participate in this randomized crossover trial. Two devices will be prepared for each patient, a hard occlusal splint (HOS) and a flexible customized mouthguard (FCM). They will wear one type of device for the first two weeks, followed by a week off, and the other type of device for the fourth and fifth week. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the HOS, and the other half wearing the FCM. The participants will rate the degree of satisfaction with the device in a 10-point scale, considering 0 extremely dissatisfied and 10 completely satisfied, and the degree of improvement or worsening of oral self-biting injuries, considering 0 an extreme worsening and 10 completely improved. They will also rate the degree of change in their quality of life (nothing, a bit, quite, a lot) because of changes in their oral self-biting injuries. Finally they will rate the compliance as the percentage of time the device was used with respect to the recommended time and report the adverse effects (excessive salivation, dry mouth, tooth pain, mucosal irritation, temporomandibular joint (TMJ) pain, TMJ sounds, bite change, other).

Official Title
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Effectiveness of Two Oral Appliances on the Degree of Satisfaction of Patients With Amyotrophic Lateral Sclerosis for Managing Oral Self-biting Injuries: a Randomized Crossover Study

Conditions
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Satisfaction

Intervention / Treatment
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* Device: Hard occlusal splint
* Device: Flexible customized mouthguard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital. Exclusion Criteria: Patients who cannot be treated due to the advanced evolution of their disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HOS-HOS-FCM-FCM sequence<br>Use of a hard occlusal splint (HOS) for the first two weeks, followed by a week off, and a flexible customized mouthguard (FCM) for the fourth and fifth week. | Device: Hard occlusal splint<br>* Use of a hard occlusal splint at times they considered helpful.<br>Device: Flexible customized mouthguard<br>* Use of a flexible customized mouthguard at times they considered helpful.<br>|
| Active Comparator: FCM-FCM-HOS-HOS sequence<br>Use of a flexible customized mouthguard (FCM) for the first two weeks, followed by a week off, and a hard occlusal splint (HOS) for the fourth and fifth week. | Device: Hard occlusal splint<br>* Use of a hard occlusal splint at times they considered helpful.<br>Device: Flexible customized mouthguard<br>* Use of a flexible customized mouthguard at times they considered helpful.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of satisfaction using a questionnarie | Participant satisfaction will be assessed by asking the question How satisfied are you with the device? using a 0-10 point scale (considering 0= extremely dissatisfied and 10 = completely satisfied) | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of improvement or worsening of oral self-biting injuries using a questionnarie | The degree of improvement or worsening of oral self-biting injuries while using the device will be assessed by asking the question How much do you think wearing the device improves the oral self-biting injuries? using a 0-10 point scale (considering 0= extreme worsening to 10= completely improved). | 1-2 weeks | 
| Degree of change in their quality of life using a questionnaire | The degree of change in their quality of life while using the device because of changes in their oral self-biting injuries will be assessed by asking the question How much do you think wearing the device improves your quality of life? using a 4-point scale (considering 0 = nothing, 1 = a bit, 2 = quite, 4 = a lot). | 1-2 weeks | 
| Compliance | Participants compliance using the device will be assessed as the percentage of time the device was used with respect to the recommended time. | 1-2 weeks | 
| Adverse effects | The adverse effects related to use of the device will be recorded (excessive salivation, dry mouth, tooth pain, mucosal irritation, temporomandibular joint (TMJ) pain, TMJ sounds, bite change, other). | 1-2 weeks | 
| Willingness to pay | Participants willingness to pay will be assessed by asking the question What is the maximum you would pay for the device? | 1-2 weeks |