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

Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809675
• Other study ID #: HOUB38/2019
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2019
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: University of Barcelona
• Contact: Nina Riera-Punet, DDS PhD
• Phone: 934035555
• Email: ninariera[@]ub.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Satisfaction

Intervention

Device:
• Hard occlusal splint
Use of a hard occlusal splint at times they considered helpful.
• Flexible customized mouthguard
Use of a flexible customized mouthguard at times they considered helpful.

Locations

Country	Name	City	State
Spain	Nina Riera-Punet	Barcelona	L'Hospitalet De Llobregat

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & 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. Winter 2018;32(1):84-90. doi: 10.11607/ofph.1882. Epub 2017 Dec 15. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of improvement or worsening of oral self-biting injuries using a questionnarie	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).	1-2 weeks
Secondary	Degree of change in their quality of life using a questionnaire	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).	1-2 weeks
Secondary	Compliance	Participants compliance using the device will be assessed as the percentage of time the device was used with respect to the recommended time.	1-2 weeks
Secondary	Adverse effects	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).	1-2 weeks
Secondary	Willingness to pay	Participants willingness to pay will be assessed by asking the question "What is the maximum you would pay for the device?"	1-2 weeks