Chewing ProblemNCT04714437
Masticatory Side Change and Masticatory Function.
A study testing F, R and L in people with Chewing Problem and Mastication Disorder, run by University of Barcelona at 1 site in Spain.
Trial summary
The primary objective of this study is to establish the effect of the frequency of masticatory side switches on masticatory performance. We also want to know the effect of the frequency of masticatory side switches on the masticatory rhythm. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chewing Problem, Mastication Disorder
- What is being tested?
- F, R and L
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years old.
- Natural dentition (minimum 24 teeth).
Who cannot join
- Active orthodontics treatment.
- Intraoral pain.
- Temporomandibular joint pain.
- Masticatory muscle pain.
- Large dental restorations.
- Dental prosthesis.
Trial locations and contacts
1 site in 1 country.
Spain1 site
School of Dentistry, University of Barcelona
L'Hospitalet de Llobregat, Catalonia, 08907
About this study
Official title: Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function.
The primary objective of this study is to establish the effect of the frequency of masticatory side switches on masticatory performance. We also want to know the effect of the frequency of masticatory side switches on the masticatory rhythm. Twenty-eight healthy volunteers will undertake masticatory tests, following a series of instructions given at the moment. These volunteers will take a re-test in two-weeks time. The sequence of these tests will be randomized in such a way that, each participant will initially perform an established sequence of "freestyle, only-right, and only-left" masticatory tests, and then will carry out one of the 6 possible combinations of "A1, A3, and A5". These tests will be recorded on video to assess, on slow playback, the change of the chewing side, and the masticatory rhythm.Masticatory performance will be determined by sieving the silicone particles.
Read the detailed description
This crossover intervention study aims to assess the effect of the degree of alternance of the chewing side on various aspects of masticatory function, including masticatory performance and rhythm. Twenty-eight volunteers will take part, recruited for convenience, among friends and relatives of the teachers and students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona. These individuals will perform masticatory tests and, after a period of two weeks, will repeat them as a re-test. Each participant will perform 6 tests, each consisting of 5 assays, chewing a small latex bag containing a few silicone tablets (2 g) during 20 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to chew the latex bag naturally. Two tests involve chewing the bag unilaterally (i.e., right-hand side in one and left-hand side in the other) and the order of their assays will be varied. For the last three tests, the participant will change the chewing side 1 (A1), 3 (A3), or 5 (A5) times respectively; the sequence of the assays will be randomized. The masticatory performance will be determined by the "median particle size" (MPS), and the masticatory rhythm will be assessed through the masticatory frequency as the ratio of masticatory cycle number to masticatory time. The control variables will include age and sex.
- Conditions
- Chewing Problem, Mastication Disorder
- Being tested
- F, R, L, A1, A3
- Keywords
- Chewing side, Masticatory side switch, Mastication, Masticatory rhythm, Masticatory performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBehavioural
The participant will be asked to chew the latex bag naturally.
RBehavioural
The participant will be asked to chew the latex bag unilaterally on the right-side.
LBehavioural
The participant will be asked to chew the latex bag unilaterally on the left-side.
A1Behavioural
The participant will be asked to chew the latex bag changing the side once.
A3Behavioural
The participant will be asked to chew the latex bag changing the side three times.
A5Behavioural
The participant will be asked to chew the latex bag changing the side five times.
| Study group | Role | What they receive |
|---|---|---|
| F-R/L-A1/A3/A5 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
| F-R/L-A1/A5/A3 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
| F-R/L-A3/A1/A5 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
| F-R/L-A3/A5/A1 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
| F-R/L-A5/A1/A3 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
| F-R/L-A5/A3/A1 Sequence | Active comparator | First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1) Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: A1; Behavioral: A3; Behavioral: A5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory performance
The masticatory performance will be calculated for each test (free, only-right, only-left, and guided tests). The particles from the 5 assays (10g) will be allowed to dry for 24 h. They will then be passed through a series of 8 sieves of different sizes (sizes are: 0.25, 0.425, 0.85, 2, 2.8, 3.15, 4 and 5.6mm). To allow the particles to pass through the sieves, they will be stirred for 6 min. The weight of the remaining pieces of silicone in each sieve will be weighed and the "Median Particle Size" (MPS) will be calculated using the Rosin Rammler formula. The MPS or (X50) is the aperture in mm of a theoretic sieve through which 50% of the weight of the particles would pass, therefore, the smaller the value of MPS, the more masticatory performance the individual has.
Measured: 1 hour 30 minutes
Masticatory Frequency
Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).
Measured: 1 hour 30 minutes
Secondary outcomes (1)
Side Switch Index
The number of side switches during the 20 masticatory cycles for each assay will be determined using slow playback of the video recordings of the freestyle mastication test. In the case that this switch is a change of side from left to right or right to left, we will assign a value of "1". If this switch consists of a change from the right or left to central or vice versa, we will assign a value of "0.5". If there is no change of side, the value assigned to this chewing cycle will be "0". To determine the Side Switch Index, the number of side changes will be divided by the maximum number of changes possible during these 5 assays (95).
Measured: 1 hour 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 Feb 2021
- Primary completion27 Mar 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chewing ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Martinez-Gomis, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714437
- Sponsor's protocol ID
- HOUB 36/2020
- Status last verified
- May 2022
- First submitted
- 11 Jan 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albert TE, Buschang PH, Throckmorton GS. Masticatory performance: a protocol for standardized production of an artificial test food. J Oral Rehabil. 2003 Jul;30(7):720-2. doi: 10.1046/j.1365-2842.2003.01155.x.
PubMed 12791158Buschang PH, Throckmorton GS, Travers KH, Johnson G. The effects of bolus size and chewing rate on masticatory performance with artificial test foods. J Oral Rehabil. 1997 Jul;24(7):522-6. doi: 10.1046/j.1365-2842.1997.00524.x.
PubMed 9250840Farias Gomes SG, Custodio W, Moura Jufer JS, Del Bel Cury AA, Rodrigues Garcia RC. Correlation of mastication and masticatory movements and effect of chewing side preference. Braz Dent J. 2010;21(4):351-5. doi: 10.1590/s0103-64402010000400011.
PubMed 20976387Flores-Orozco EI, Tiznado-Orozco GE, Osuna-Gonzalez OD, Amaro-Navarrete CL, Rovira-Lastra B, Martinez-Gomis J. Lack of relationship between masticatory performance and nutritional status in adults with natural dentition. Arch Oral Biol. 2016 Nov;71:117-121. doi: 10.1016/j.archoralbio.2016.07.008. Epub 2016 Jul 29.
PubMed 27494213Julien KC, Buschang PH, Throckmorton GS, Dechow PC. Normal masticatory performance in young adults and children. Arch Oral Biol. 1996 Jan;41(1):69-75. doi: 10.1016/0003-9969(95)00098-4.
PubMed 8833593Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.
PubMed 29241026Remijn L, Groen BE, Speyer R, van Limbeek J, Nijhuis-van der Sanden MW. Reproducibility of 3D kinematics and surface electromyography measurements of mastication. Physiol Behav. 2016 Mar 1;155:112-21. doi: 10.1016/j.physbeh.2015.11.018. Epub 2015 Nov 23.
PubMed 26617403Rovira-Lastra B, Flores-Orozco EI, Salsench J, Peraire M, Martinez-Gomis J. Is the side with the best masticatory performance selected for chewing? Arch Oral Biol. 2014 Dec;59(12):1316-20. doi: 10.1016/j.archoralbio.2014.08.005. Epub 2014 Aug 18.
PubMed 25173664Mioche L, Hiiemae KM, Palmer JB. A postero-anterior videofluorographic study of the intra-oral management of food in man. Arch Oral Biol. 2002 Apr;47(4):267-80. doi: 10.1016/s0003-9969(02)00007-9.
PubMed 11922870Khoury-Ribas L, Ignatova-Mishutina T, Rovira-Lastra B, Ayuso-Montero R, Martinez-Gomis J. Impact of Treatment with Unilateral Implant- Supported Fixed Partial Prosthesis on the Frequency of Masticatory Side Switches in Patients with Unilateral Posterior Missing Teeth. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):245-251. doi: 10.1922/EJPRD_2336Khoury-Ribas07.
PubMed 35107226Ignatova-Mishutina T, Khoury-Ribas L, Flores-Orozco EI, Rovira-Lastra B, Martinez-Gomis J. Effect of side switch frequency on masticatory performance and rhythm in adults with natural dentition: A randomised crossover trial. J Oral Rehabil. 2022 Apr;49(4):373-380. doi: 10.1111/joor.13308. Epub 2022 Feb 12.
PubMed 35108409
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Frequency of Masticatory Side Switches and Aspects of Masticatory Function.
- ClinicalTrials.gov ID
- NCT04714437
- Acronym / sponsor ID
- HOUB 36/2020
- Conditions
- Chewing Problem, Mastication Disorder
- Keywords
- Chewing side, Masticatory side switch, Mastication, Masticatory rhythm, Masticatory performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to establish the effect of the frequency of masticatory side switches on masticatory performance. We also want to know the effect of the frequency of masticatory side switches on the masticatory rhythm. Twenty-eight healthy volunteers will undertake masticatory tests, following a series of instructions given at the moment. These volunteers will take a re-test in two-weeks time. The sequence of these tests will be randomized in such a way that, each participant will initially perform an established sequence of "freestyle, only-right, and only-left" masticatory tests, and then will carry out one of the 6 possible combinations of "A1, A3, and A5". These tests will be recorded on video to assess, on slow playback, the change of the chewing side, and the masticatory rhythm.Masticatory performance will be determined by sieving the silicone particles.
Detailed description
This crossover intervention study aims to assess the effect of the degree of alternance of the chewing side on various aspects of masticatory function, including masticatory performance and rhythm. Twenty-eight volunteers will take part, recruited for convenience, among friends and relatives of the teachers and students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona. These individuals will perform masticatory tests and, after a period of two weeks, will repeat them as a re-test. Each participant will perform 6 tests, each consisting of 5 assays, chewing a small latex bag containing a few silicone tablets (2 g) during 20 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to chew the latex bag naturally. Two tests involve chewing the bag unilaterally (i.e., right-hand side in one and left-hand side in the other) and the order of their assays will be varied. For the last three tests, the participant will change the chewing side 1 (A1), 3 (A3), or 5 (A5) times respectively; the sequence of the assays will be randomized. The masticatory performance will be determined by the "median particle size" (MPS), and the masticatory rhythm will be assessed through the masticatory frequency as the ratio of masticatory cycle number to masticatory time. The control variables will include age and sex.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| F-R/L-A1/A3/A5 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5) |
| F-R/L-A1/A5/A3 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3) |
| F-R/L-A3/A1/A5 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5) |
| F-R/L-A3/A5/A1 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A3-A5-A1-A1-A5-A3-A3-A5-A1-A1-A5-A3-A3-A5-A1) |
| F-R/L-A5/A1/A3 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A1-A3-A3-A1-A5-A5-A1-A3-A3-A1-A5-A5-A1-A3) |
| F-R/L-A5/A3/A1 Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: A1, Behavioral: A3, Behavioral: A5First, 5 freestyle masticatory assays (F). Second, 5 only-right (R) and 5 only-left (L) masticatory assays in the following order (R-L-L-R-R-L-L-R-R-L) Third, 15 masticatory assays changing the side once (A1), three times (A3) or 5 times (A5) in the following order (A5-A3-A1-A1-A3-A5-A5-A3-A1-A1-A3-A5-A5-A3-A1) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years old.
- Natural dentition (minimum 24 teeth).
Key exclusion criteria (6 listed)
- Active orthodontics treatment.
- Intraoral pain.
- Temporomandibular joint pain.
- Masticatory muscle pain.
- Large dental restorations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FThe participant will be asked to chew the latex bag naturally. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
| RThe participant will be asked to chew the latex bag unilaterally on the right-side. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
| LThe participant will be asked to chew the latex bag unilaterally on the left-side. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
| A1The participant will be asked to chew the latex bag changing the side once. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
| A3The participant will be asked to chew the latex bag changing the side three times. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
| A5The participant will be asked to chew the latex bag changing the side five times. | Behavioural | F-R/L-A1/A3/A5 Sequence, F-R/L-A1/A5/A3 Sequence, F-R/L-A3/A1/A5 Sequence, F-R/L-A3/A5/A1 Sequence, F-R/L-A5/A1/A3 Sequence, F-R/L-A5/A3/A1 Sequence |
Primary outcome
Masticatory performance
Time frame: 1 hour 30 minutes
The masticatory performance will be calculated for each test (free, only-right, only-left, and guided tests). The particles from the 5 assays (10g) will be allowed to dry for 24 h. They will then be passed through a series of 8 sieves of different sizes (sizes are: 0.25, 0.425, 0.85, 2, 2.8, 3.15, 4 and 5.6mm). To allow the particles to pass through the sieves, they will be stirred for 6 min. The weight of the remaining pieces of silicone in each sieve will be weighed and the "Median Particle Size" (MPS) will be calculated using the Rosin Rammler formula. The MPS or (X50) is the aperture in mm of a theoretic sieve through which 50% of the weight of the particles would pass, therefore, the smaller the value of MPS, the more masticatory performance the individual has.
Masticatory Frequency
Time frame: 1 hour 30 minutes
Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).
1 secondary outcome
Side Switch Index
Time frame: 1 hour 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 12791158Albert TE, Buschang PH, Throckmorton GS. Masticatory performance: a protocol for standardized production of an artificial test food. J Oral Rehabil. 2003 Jul;30(7):720-2. doi: 10.1046/j.1365-2842.2003.01155.x.
- Background: PubMed 9250840Buschang PH, Throckmorton GS, Travers KH, Johnson G. The effects of bolus size and chewing rate on masticatory performance with artificial test foods. J Oral Rehabil. 1997 Jul;24(7):522-6. doi: 10.1046/j.1365-2842.1997.00524.x.
- Background: PubMed 20976387Farias Gomes SG, Custodio W, Moura Jufer JS, Del Bel Cury AA, Rodrigues Garcia RC. Correlation of mastication and masticatory movements and effect of chewing side preference. Braz Dent J. 2010;21(4):351-5. doi: 10.1590/s0103-64402010000400011.
- Background: PubMed 27494213Flores-Orozco EI, Tiznado-Orozco GE, Osuna-Gonzalez OD, Amaro-Navarrete CL, Rovira-Lastra B, Martinez-Gomis J. Lack of relationship between masticatory performance and nutritional status in adults with natural dentition. Arch Oral Biol. 2016 Nov;71:117-121. doi: 10.1016/j.archoralbio.2016.07.008. Epub 2016 Jul 29.
- Background: PubMed 8833593Julien KC, Buschang PH, Throckmorton GS, Dechow PC. Normal masticatory performance in young adults and children. Arch Oral Biol. 1996 Jan;41(1):69-75. doi: 10.1016/0003-9969(95)00098-4.
- Background: PubMed 29241026Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.
- Background: PubMed 26617403Remijn L, Groen BE, Speyer R, van Limbeek J, Nijhuis-van der Sanden MW. Reproducibility of 3D kinematics and surface electromyography measurements of mastication. Physiol Behav. 2016 Mar 1;155:112-21. doi: 10.1016/j.physbeh.2015.11.018. Epub 2015 Nov 23.
- Background: PubMed 25173664Rovira-Lastra B, Flores-Orozco EI, Salsench J, Peraire M, Martinez-Gomis J. Is the side with the best masticatory performance selected for chewing? Arch Oral Biol. 2014 Dec;59(12):1316-20. doi: 10.1016/j.archoralbio.2014.08.005. Epub 2014 Aug 18.
- Background: PubMed 11922870Mioche L, Hiiemae KM, Palmer JB. A postero-anterior videofluorographic study of the intra-oral management of food in man. Arch Oral Biol. 2002 Apr;47(4):267-80. doi: 10.1016/s0003-9969(02)00007-9.
- Background: PubMed 35107226Khoury-Ribas L, Ignatova-Mishutina T, Rovira-Lastra B, Ayuso-Montero R, Martinez-Gomis J. Impact of Treatment with Unilateral Implant- Supported Fixed Partial Prosthesis on the Frequency of Masticatory Side Switches in Patients with Unilateral Posterior Missing Teeth. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):245-251. doi: 10.1922/EJPRD_2336Khoury-Ribas07.
- Results publication: PubMed 35108409Ignatova-Mishutina T, Khoury-Ribas L, Flores-Orozco EI, Rovira-Lastra B, Martinez-Gomis J. Effect of side switch frequency on masticatory performance and rhythm in adults with natural dentition: A randomised crossover trial. J Oral Rehabil. 2022 Apr;49(4):373-380. doi: 10.1111/joor.13308. Epub 2022 Feb 12.
- Mizumori T, Arai K, Tsubakimoto T, Yatani H. Chewing side continuity and masticatory performance. Prosthodont Res Pract. 2006;5:10-4.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F, R and L in people with Chewing Problem and Mastication Disorder, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masticatory performance (time frame: 1 hour 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714437, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.