- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173259
Masticatory Side-switch and Mixing Ability.
Effect of Side Switch Frequency on Masticatory Mixing Ability and Perception of Taste, Muscular Fatigue and Saliva Production: A Randomized Crossover Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Catalonia
-
L'Hospitalet De Llobregat, Catalonia, Spain, 08907
- School of Dentistry, University of Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older than 18 years old.
- Natural dentition (minimum 24 teeth)
Exclusion Criteria:
- Active orthodontics treatment.
- Intraoral pain.
- Temporomandibular joint pain.
- Masticatory muscle pain.
- Large dental restorations.
- Dental prosthesis.
- Edentulous spaces.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: F-R/L-G05/G15/G25 or G25/G15/G05-L/R-F Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
Active Comparator: F-R/L-G05/G25/G15 or G15/G25/G05-F-L/R Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
Active Comparator: F-R/L-G15/G05/G25 or G25/G05/G15-F-L/R Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
Active Comparator: F-R/L-G15/G25/G05 or G05/G25/G15-F-L/R Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
Active Comparator: F-R/L-G25/G05/G15 or G15/G05/G25-F-L/R Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
Active Comparator: F-R/L-G25/G15/G05 or G05/G15/G25-F-L/R Sequence
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). |
The participant will be asked to chew the two-coloured chewing gum naturally.
The participant will be asked to chew the two-coloured chewing gum on the right-side.
The participant will be asked to chew the two-coloured chewing gum on the left-side.
The participant will be asked to chew the two-coloured chewing gum changing the side in 5%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 15%.
The participant will be asked to chew the two-coloured chewing gum changing the side in 25%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
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).
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Masticatory Frequency
Time Frame: 1 hour
|
Masticatory frequency will be assessed as the ratio of masticatory cycle number to masticatory time (in cycles per minute).
|
1 hour
|
Degree of muscular fatigue during this masticatory assay
Time Frame: 1 hour
|
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.
|
1 hour
|
Degree of salivary secretion during this masticatory assay
Time Frame: 1 hour
|
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.
|
1 hour
|
Degree of taste perception during this masticatory assay
Time Frame: 1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Schimmel 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.
- 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.
- van 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.
- Mizumori 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.
- Flores-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.
- Mioche 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.
- Woda 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.
- Remijn 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.
- Mizumori 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.
- van 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.
- Montero 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.
- Yousof 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.
- van 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HOUB 44/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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