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

NCT ID: NCT04809675

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2021-12-31

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).

Conditions

Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hard occlusal splint

Intervention Type: DEVICE

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

Flexible customized mouthguard

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Hard occlusal splint

Intervention Type: DEVICE

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

Flexible customized mouthguard

Intervention Type: DEVICE

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

Interventions

Hard occlusal splint

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

Intervention Type: DEVICE

Flexible customized mouthguard

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Nina Riera-Punet

Associate professor DDS PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nina Riera-Punet

Barcelona, L'Hospitalet de Llobregat, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Nina Riera-Punet, DDS PhD

Role: CONTACT

ninariera@ub.edu

934035555 ext. +34

Facility Contacts

Nina Riera-Punet

Role: primary

ninariera@ub.edu

93403555 ext. +34

References

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.

Reference Type: BACKGROUND

PMID: 29244892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29240971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30503152 (View on PubMed)

Other Identifiers

HOUB38/2019

Identifier Type: -

Identifier Source: org_study_id