Chewing ProblemNCT05173259
Masticatory Side-switch and Mixing Ability.
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 main aim of this cross-over intervention study is to assess the effect of masticatory side-switch frequency on different aspects of masticatory function, including masticatory mixing ability and 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
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 28 Sep 2022
- 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.
- Edentulous spaces.
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: Effect of Side Switch Frequency on Masticatory Mixing Ability and Perception of Taste, Muscular Fatigue and Saliva Production: A Randomized Crossover Trial.
The main aim of this cross-over intervention study is to assess the effect of masticatory side-switch frequency on different aspects of masticatory function, including masticatory mixing ability and rhythm. A secondary aim is to explore the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. The tests will be randomised masticatory sequences of "free-style", "unilateral-right", "unilateral-left", switching the chewing side at 5% "G05", at 15% "G15" and at 25% "G25". Video recordings of these tests will be made to later assess, on slow playback, the change of the chewing side and the masticatory rhythm. The masticatory mixing ability will be determined through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R).
Read the detailed description
This this cross-over intervention study aims to assess the effect of masticatory side-switch frequency on different objective aspects of masticatory function, including masticatory mixing ability and rhythm, as well as the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Each of the thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to masticate the chewing gum. Two tests involve chewing the gum unilaterally (i.e., only on the right-hand side, and only on the left) varying the order of these assays. In the last three tests, the volunteer will switch chewing side in 5% (G05), 15% (G15), or 25% (G25) respectively; the sequence of the assays will be randomized. Twenty-four of these volunteers will be randomly selected to repeat these tests after a period of two weeks. The masticatory mixing ability will be determined through the "mixing capacity index" (MCI), obtained from through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R), 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, G05, G15
- Keywords
- Chewing side, Masticatory side-switch, Mastication, Masticatory rhythm, Masticatory performance, Masticatory mixing ability
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 two-coloured chewing gum naturally.
RBehavioural
The participant will be asked to chew the two-coloured chewing gum on the right-side.
LBehavioural
The participant will be asked to chew the two-coloured chewing gum on the left-side.
G05Behavioural
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
G15Behavioural
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
G25Behavioural
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
| Study group | Role | What they receive |
|---|---|---|
| F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
| F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
| F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G05-G25-G25-G05-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
| F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
| F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
| F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence | Active comparator | First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25).
Or
First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). Receives: Behavioral: F; Behavioral: R; Behavioral: L; Behavioral: G05; Behavioral: G15; Behavioral: G25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory mixing ability
Masticatory mixing ability will be calculated from the mixing capacity for each type of test (free, right, left and guided). Chewing gum will flattened between two rigid surfaces to a thickness of 1.5 mm. The two sides of the chewing gum will then be scanned at a resolution of 300 dpi. The images will be processed with "ImageJ" with the "Color-Histogram" plugin. Before mixing, the green and red color of the chewing gum are represented in the histogram of the red channel as two separate peaks: one in low intensity and one in high intensity, representing the green and red color of chewing gum, respectively. After mixing, the colors are mixed and so the two peaks merge into one peak. The standard deviation of the intensity distribution is taken as a measure of the mixture of the two colors in the chewing gum. The standard deviation at an early stage of mixing is relatively high, and decreases as the colors are mixed; thus, a high value of the mixing index means a high mixing capacity.
Measured: 1 hour
Side-switch Index
The number of side switches during the 40 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 (78).
Measured: 1 hour
Secondary outcomes (4)
Masticatory Frequency
Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).
Measured: 1 hour
Degree of muscular fatigue during this masticatory assay
The degree of muscular fatigue while chewed the gum was assessed by asking the question "How much muscular fatigue do you think this masticatory test caused you?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Participants will rate the masticatory test after each assay.
Measured: 1 hour
Degree of salivary secretion during this masticatory assay
The degree of salivary secretion while chewed the gum was assessed by asking the question "How much saliva secretion do you think this masticatory test caused you?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Participants will rate the masticatory test after each assay.
Measured: 1 hour
Degree of taste perception during this masticatory assay
The degree of taste perception while chewed the gum was assessed by asking the question "To what degree do you think this masticatory test facilitates taste perception?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Participants will rate the masticatory test after each assay.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Mar 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- 36 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
- NCT05173259
- Sponsor's protocol ID
- HOUB 44/2021
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Bilt A. Assessment of mastication with implications for oral rehabilitation: a review. J Oral Rehabil. 2011 Oct;38(10):754-80. doi: 10.1111/j.1365-2842.2010.02197.x. Epub 2011 Jan 17.
PubMed 21241351van der Bilt A, Abbink JH. The influence of food consistency on chewing rate and muscular work. Arch Oral Biol. 2017 Nov;83:105-110. doi: 10.1016/j.archoralbio.2017.07.011. Epub 2017 Jul 20.
PubMed 28750270Mizumori T, Tsubakimoto T, Iwasaki M, Nakamura T. Masticatory laterality--evaluation and influence of food texture. J Oral Rehabil. 2003 Oct;30(10):995-9. doi: 10.1046/j.1365-2842.2003.01086.x.
PubMed 12974859Flores-Orozco EI, Rovira-Lastra B, Peraire M, Salsench J, Martinez-Gomis J. Reliability of a visual analog scale for determining the preferred mastication side. J Prosthet Dent. 2016 Feb;115(2):203-8. doi: 10.1016/j.prosdent.2015.07.006. Epub 2015 Oct 9.
PubMed 26455536Mioche 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 11922870Woda A, Foster K, Mishellany A, Peyron MA. Adaptation of healthy mastication to factors pertaining to the individual or to the food. Physiol Behav. 2006 Aug 30;89(1):28-35. doi: 10.1016/j.physbeh.2006.02.013. Epub 2006 Apr 3.
PubMed 16581096Remijn 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 26617403Mizumori T, Arai K. Tsubakimoto T, Yatani H. Chewing side continuity and masticatory performance. Prosthodont Res Pract 2006;5:10-4.
Weijenberg RA, Scherder EJ, Visscher CM, Gorissen T, Yoshida E, Lobbezoo F. Two-colour chewing gum mixing ability: digitalisation and spatial heterogeneity analysis. J Oral Rehabil. 2013 Oct;40(10):737-43. doi: 10.1111/joor.12090. Epub 2013 Aug 9.
PubMed 23927753van der Bilt A, Speksnijder CM, de Liz Pocztaruk R, Abbink JH. Digital image processing versus visual assessment of chewed two-colour wax in mixing ability tests. J Oral Rehabil. 2012 Jan;39(1):11-7. doi: 10.1111/j.1365-2842.2011.02229.x. Epub 2011 Jun 27.
PubMed 21707695Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
PubMed 26111925Montero J, Leiva LA, Martin-Quintero I, Barrios-Rodriguez R. Chewing Performance Calculator: An interactive clinical method for quantifying masticatory performance. J Prosthet Dent. 2021 Jan;125(1):82-88. doi: 10.1016/j.prosdent.2019.10.006. Epub 2020 Jan 25.
PubMed 31987585Yousof Y, Salleh NM, Yusof F. Quantitative Evaluation of Masticatory Performance with Two-Color Mixing Ability Test: Development of a New Digital Method. Int J Prosthodont. 2020 Mar/Apr;33(2):224-228. doi: 10.11607/ijp.6568.
PubMed 32069348van der Bilt A, Mojet J, Tekamp FA, Abbink JH. Comparing masticatory performance and mixing ability. J Oral Rehabil. 2010 Feb;37(2):79-84. doi: 10.1111/j.1365-2842.2009.02040.x. Epub 2009 Dec 7.
PubMed 19968766
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Side Switch Frequency on Masticatory Mixing Ability and Perception of Taste, Muscular Fatigue and Saliva Production: A Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT05173259
- Acronym / sponsor ID
- HOUB 44/2021
- Conditions
- Chewing Problem, Mastication Disorder
- Keywords
- Chewing side, Masticatory side-switch, Mastication, Masticatory rhythm, Masticatory performance, Masticatory mixing ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 29 Dec 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 main aim of this cross-over intervention study is to assess the effect of masticatory side-switch frequency on different aspects of masticatory function, including masticatory mixing ability and rhythm. A secondary aim is to explore the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. The tests will be randomised masticatory sequences of "free-style", "unilateral-right", "unilateral-left", switching the chewing side at 5% "G05", at 15% "G15" and at 25% "G25". Video recordings of these tests will be made to later assess, on slow playback, the change of the chewing side and the masticatory rhythm. The masticatory mixing ability will be determined through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R).
Detailed description
This this cross-over intervention study aims to assess the effect of masticatory side-switch frequency on different objective aspects of masticatory function, including masticatory mixing ability and rhythm, as well as the subjective perception of taste, muscular fatigue, and saliva production through a VAS. Each of the thirty-six volunteers recruited for convenience, among students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona, will perform 6 tests, each consisting of 2 assays, chewing a two-coloured chewing gum, during 40 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to masticate the chewing gum. Two tests involve chewing the gum unilaterally (i.e., only on the right-hand side, and only on the left) varying the order of these assays. In the last three tests, the volunteer will switch chewing side in 5% (G05), 15% (G15), or 25% (G25) respectively; the sequence of the assays will be randomized. Twenty-four of these volunteers will be randomly selected to repeat these tests after a period of two weeks. The masticatory mixing ability will be determined through the "mixing capacity index" (MCI), obtained from through the scanning and posterior analysis of the red-channel in the histogram plug-in in "ImageJ" (R), 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-G05/G15/G25 or G25/G15/G05-L/R-F Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
| F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G25-G15-G15-G25-G05). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
| F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G05-G15-G25-G25-G15-G05). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G05-G25-G25-G05-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
| F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G15-G25-G05-G05-G25-G15). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
| F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G05-G15-G15-G05-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
| F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence | Active comparator | Behavioral: F, Behavioral: R, Behavioral: L, Behavioral: G05, Behavioral: G15, Behavioral: G25First, 2 freestyle masticatory assays (F). Second, 2 only-right (R) and 2 only-left (L) masticatory assays in the following order (R-L-L-R). Third, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25). Or First, 6 masticatory assays changing in 5% (G05), 15% (G15) or 25% (G25) in the following order (G25-G15-G05-G05-G15-G25). Second, 2 only-left (L) and 2 only-right (R) masticatory assays in the following order (L-R-R-L). Third, 2 freestyle masticatory assays (F). |
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 (7 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 two-coloured chewing gum naturally. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
| RThe participant will be asked to chew the two-coloured chewing gum on the right-side. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
| LThe participant will be asked to chew the two-coloured chewing gum on the left-side. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
| G05The participant will be asked to chew the two-coloured chewing gum changing the side in 5%. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
| G15The participant will be asked to chew the two-coloured chewing gum changing the side in 15%. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
| G25The participant will be asked to chew the two-coloured chewing gum changing the side in 25%. | Behavioural | F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence, F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence, F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence, F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence, F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence, F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence |
Primary outcome
Masticatory mixing ability
Time frame: 1 hour
Masticatory mixing ability will be calculated from the mixing capacity for each type of test (free, right, left and guided). Chewing gum will flattened between two rigid surfaces to a thickness of 1.5 mm. The two sides of the chewing gum will then be scanned at a resolution of 300 dpi. The images will be processed with "ImageJ" with the "Color-Histogram" plugin. Before mixing, the green and red color of the chewing gum are represented in the histogram of the red channel as two separate peaks: one in low intensity and one in high intensity, representing the green and red color of chewing gum, respectively. After mixing, the colors are mixed and so the two peaks merge into one peak. The standard deviation of the intensity distribution is taken as a measure of the mixture of the two colors in the chewing gum. The standard deviation at an early stage of mixing is relatively high, and decreases as the colors are mixed; thus, a high value of the mixing index means a high mixing capacity.
Side-switch Index
Time frame: 1 hour
The number of side switches during the 40 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 (78).
4 secondary outcomes
Masticatory Frequency
Time frame: 1 hour
Degree of muscular fatigue during this masticatory assay
Time frame: 1 hour
Degree of salivary secretion during this masticatory assay
Time frame: 1 hour
Degree of taste perception during this masticatory assay
Time frame: 1 hour
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 3 Nov 2022.
- Background: PubMed 21241351van der Bilt A. Assessment of mastication with implications for oral rehabilitation: a review. J Oral Rehabil. 2011 Oct;38(10):754-80. doi: 10.1111/j.1365-2842.2010.02197.x. Epub 2011 Jan 17.
- Background: PubMed 28750270van der Bilt A, Abbink JH. The influence of food consistency on chewing rate and muscular work. Arch Oral Biol. 2017 Nov;83:105-110. doi: 10.1016/j.archoralbio.2017.07.011. Epub 2017 Jul 20.
- Background: PubMed 12974859Mizumori T, Tsubakimoto T, Iwasaki M, Nakamura T. Masticatory laterality--evaluation and influence of food texture. J Oral Rehabil. 2003 Oct;30(10):995-9. doi: 10.1046/j.1365-2842.2003.01086.x.
- Background: PubMed 26455536Flores-Orozco EI, Rovira-Lastra B, Peraire M, Salsench J, Martinez-Gomis J. Reliability of a visual analog scale for determining the preferred mastication side. J Prosthet Dent. 2016 Feb;115(2):203-8. doi: 10.1016/j.prosdent.2015.07.006. Epub 2015 Oct 9.
- 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 16581096Woda A, Foster K, Mishellany A, Peyron MA. Adaptation of healthy mastication to factors pertaining to the individual or to the food. Physiol Behav. 2006 Aug 30;89(1):28-35. doi: 10.1016/j.physbeh.2006.02.013. Epub 2006 Apr 3.
- 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.
- BackgroundMizumori T, Arai K. Tsubakimoto T, Yatani H. Chewing side continuity and masticatory performance. Prosthodont Res Pract 2006;5:10-4.
- Background: PubMed 23927753Weijenberg RA, Scherder EJ, Visscher CM, Gorissen T, Yoshida E, Lobbezoo F. Two-colour chewing gum mixing ability: digitalisation and spatial heterogeneity analysis. J Oral Rehabil. 2013 Oct;40(10):737-43. doi: 10.1111/joor.12090. Epub 2013 Aug 9.
- Background: PubMed 21707695van der Bilt A, Speksnijder CM, de Liz Pocztaruk R, Abbink JH. Digital image processing versus visual assessment of chewed two-colour wax in mixing ability tests. J Oral Rehabil. 2012 Jan;39(1):11-7. doi: 10.1111/j.1365-2842.2011.02229.x. Epub 2011 Jun 27.
- Background: PubMed 26111925Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
- Background: PubMed 31987585Montero J, Leiva LA, Martin-Quintero I, Barrios-Rodriguez R. Chewing Performance Calculator: An interactive clinical method for quantifying masticatory performance. J Prosthet Dent. 2021 Jan;125(1):82-88. doi: 10.1016/j.prosdent.2019.10.006. Epub 2020 Jan 25.
- Individual participant dataSharing planned: Undecided
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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 7 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 3 Nov 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 mixing ability (time frame: 1 hour). 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 NCT05173259, which also lists 14 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 3 Nov 2022; AzTrials last refreshed its copy on 27 Oct 2026.