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

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

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: March 22, 2021
• Last Update Posted Date: March 22, 2021
• Actual Study Start Date: November 29, 2019
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 18, 2021)

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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 18, 2021)

• 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).
• 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).
• 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.
• 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).
• 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?"

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Two Oral Appliances for Managing Oral Self-biting Injuries in Patients With ALS
• 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
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Satisfaction

Intervention

• 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.

Study Arms

• 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.
  Interventions:

  • Device: Hard occlusal splint
  • Device: Flexible customized mouthguard
• 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.
  Interventions:

  • Device: Hard occlusal splint
  • Device: Flexible customized mouthguard

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 18, 2021): 31
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04809675
• Other Study ID Numbers: HOUB38/2019
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nina Riera-Punet, University of Barcelona
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Barcelona
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Barcelona
• Verification Date: March 2021