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

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ClinicalTrials.gov Identifier: NCT04809675
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Nina Riera-Punet, University of Barcelona

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.

Condition or disease Intervention/treatment Phase
Satisfaction Device: Hard occlusal splint Device: Flexible customized mouthguard Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 29, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Degree of satisfaction using a questionnarie [ Time Frame: 1-2 weeks ]
    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)


Secondary Outcome Measures :
  1. Degree of improvement or worsening of oral self-biting injuries using a questionnarie [ Time Frame: 1-2 weeks ]
    The degree of improvement or worsening of oral self-biting injuries while using the device will be assessed by asking the question "How much do you think wearing the device improves the oral self-biting injuries?" using a 0-10 point scale (considering 0= extreme worsening to 10= completely improved).

  2. Degree of change in their quality of life using a questionnaire [ Time Frame: 1-2 weeks ]
    The degree of change in their quality of life while using the device because of changes in their oral self-biting injuries will be assessed by asking the question "How much do you think wearing the device improves your quality of life?" using a 4-point scale (considering 0 = nothing, 1 = a bit, 2 = quite, 4 = a lot).

  3. Compliance [ Time Frame: 1-2 weeks ]
    Participants compliance using the device will be assessed as the percentage of time the device was used with respect to the recommended time.

  4. Adverse effects [ Time Frame: 1-2 weeks ]
    The adverse effects related to use of the device will be recorded (excessive salivation, dry mouth, tooth pain, mucosal irritation, temporomandibular joint (TMJ) pain, TMJ sounds, bite change, other).

  5. Willingness to pay [ Time Frame: 1-2 weeks ]
    Participants willingness to pay will be assessed by asking the question "What is the maximum you would pay for the device?"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809675


Contacts
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Contact: Nina Riera-Punet, DDS PhD 934035555 ext +34 ninariera@ub.edu

Locations
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Spain
Nina Riera-Punet Recruiting
Barcelona, L'Hospitalet De Llobregat, Spain, 08907
Contact: Nina Riera-Punet    93403555 ext +34    ninariera@ub.edu   
Sponsors and Collaborators
University of Barcelona
Publications:
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Responsible Party: Nina Riera-Punet, Associate professor DDS PhD, University of Barcelona
ClinicalTrials.gov Identifier: NCT04809675    
Other Study ID Numbers: HOUB38/2019
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents