Study Purpose: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.
Type of Intervention:
Hard occlusal splint, Flexible customized mouthguard
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
Full Study Summary:
University of Barcelona
Estimated Study Start Date:
11 / 29 / 2019
Estimated Study Completion Date:
12 / 01 / 2021
Posting Last Modified Date:
03 / 22 / 2021
Date Study Added to neals.org:
03 / 22 / 2021
- Patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital.
- Patients who cannot be treated due to the advanced evolution of their disease.
Nina Riera-Punet | Recruiting
Barcelona, L'Hospitalet De Llobregat