NCT04809675

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

April 8, 2020

Last Update Submit

March 18, 2021

Conditions

Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Degree of satisfaction using a questionnarie

    Participant satisfaction will be assessed by asking the question "How satisfied are you with the device?" using a 0-10 point scale (considering 0= extremely dissatisfied and 10 = completely satisfied)

    1-2 weeks

Secondary Outcomes (5)

  • Degree of improvement or worsening of oral self-biting injuries using a questionnarie

    1-2 weeks

  • Degree of change in their quality of life using a questionnaire

    1-2 weeks

  • Compliance

    1-2 weeks

  • Adverse effects

    1-2 weeks

  • Willingness to pay

    1-2 weeks

Study Arms (2)

HOS-HOS-FCM-FCM sequence

ACTIVE COMPARATOR

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.

Device: Hard occlusal splintDevice: Flexible customized mouthguard

FCM-FCM-HOS-HOS sequence

ACTIVE COMPARATOR

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.

Device: Hard occlusal splintDevice: Flexible customized mouthguard

Interventions

Hard occlusal splintDEVICE

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

FCM-FCM-HOS-HOS sequenceHOS-HOS-FCM-FCM sequence
Flexible customized mouthguardDEVICE

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

FCM-FCM-HOS-HOS sequenceHOS-HOS-FCM-FCM sequence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital.

You may not qualify if:

  • Patients who cannot be treated due to the advanced evolution of their disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nina Riera-Punet

Barcelona, L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29244892BACKGROUND

  • 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.

    PMID: 29240971BACKGROUND

  • 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.

    PMID: 30503152BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Nina Riera-Punet, DDS PhD

CONTACT

934035555ninariera@ub.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor DDS PhD

Study Record Dates

First Submitted

April 8, 2020

First Posted

March 22, 2021

Study Start

November 29, 2019

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

ES(1)