Clinical trial NCT04809675: Effectiveness of Two Oral Appliances for Managing Oral Self-biting Injuries in Patients With ALS
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Satisfaction
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of satisfaction using a questionnarie
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Degree of improvement or worsening of oral self-biting injuries using a questionnarie
timeFrame: 1-2 weeks
measure: Degree of change in their quality of life using a questionnaire
timeFrame: 1-2 weeks
measure: Compliance
timeFrame: 1-2 weeks
measure: Adverse effects
timeFrame: 1-2 weeks
measure: Willingness to pay
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Nina Riera-Punet
state: L'Hospitalet De Llobregat
Study officials:
References:
citation: Riera-Punet N, Martinez-Gomis J, Paipa A, Povedano M, Peraire M. Alterations in the Masticatory System in Patients with Amyotrophic Lateral Sclerosis. J Oral Facial Pain Headache. 2018 Winter;32(1):84-90. doi: 10.11607/ofph.1882. Epub 2017 Dec 15.
citation: Riera-Punet N, Martinez-Gomis J, Willaert E, Povedano M, Peraire M. Functional limitation of the masticatory system in patients with bulbar involvement in amyotrophic lateral sclerosis. J Oral Rehabil. 2018 Mar;45(3):204-210. doi: 10.1111/joor.12597. Epub 2017 Dec 30.
citation: Riera-Punet N, Martinez-Gomis J, Zamora-Olave C, Willaert E, Peraire M. Satisfaction of patients with amyotrophic lateral sclerosis with an oral appliance for managing oral self-biting injuries and alterations in their masticatory system: A case-series study. J Prosthet Dent. 2019 Apr;121(4):631-636. doi: 10.1016/j.prosdent.2018.06.010. Epub 2018 Nov 30.