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

NCT04809675 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

  • Satisfaction

Interventions

DEVICE

Hard occlusal splint

Use of a hard occlusal splint at times they considered helpful.

DEVICE

Flexible customized mouthguard

Use of a flexible customized mouthguard at times they considered helpful.

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809675 on ClinicalTrials.gov