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

University of Barcelona

Status: Unknown

Conditions: Satisfaction

Treatments: Device: Hard occlusal splint; Device: Flexible customized mouthguard

Study type: Interventional

Funder types: Other

Identifiers

NCT04809675

HOUB38/2019

Details and patient eligibility

About

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.

Full 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).

Enrollment: 31 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

HOS-HOS-FCM-FCM sequence

Active Comparator group

Description:

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.

Treatment:

Device: Hard occlusal splint

Device: Flexible customized mouthguard

FCM-FCM-HOS-HOS sequence

Active Comparator group

Description:

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.

Treatment:

Device: Hard occlusal splint

Device: Flexible customized mouthguard