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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Barcelona
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Degree of satisfaction using a questionnarie
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HOS-HOS-FCM-FCM sequence
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.
Intervention: Hard occlusal splint (Device)
HOS-HOS-FCM-FCM sequence
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.
Intervention: Flexible customized mouthguard (Device)
FCM-FCM-HOS-HOS sequence
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.
Intervention: Hard occlusal splint (Device)
FCM-FCM-HOS-HOS sequence
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.
Intervention: Flexible customized mouthguard (Device)
Outcomes
Primary Outcomes
Degree of satisfaction using a questionnarie
Time Frame: 1-2 weeks
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)
Secondary Outcomes
- Degree of improvement or worsening of oral self-biting injuries using a questionnarie(1-2 weeks)
- Degree of change in their quality of life using a questionnaire(1-2 weeks)
- Compliance(1-2 weeks)
- Adverse effects(1-2 weeks)
- Willingness to pay(1-2 weeks)
Investigators
Nina Riera-Punet
Associate professor DDS PhD
University of Barcelona