FaciesNCT01286363
Facial Patterns and Masticatory Symmetries
An observational study of Facies, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of occlusal contact area and bite force of individuals with different craniofacial patterns Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Facies
- How many people
- 86 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Dec 2008
- Phase
- Observational
- 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students and staff of Piracicaba Dental School, and individuals seeking for dental treatment at the same institution
Who may be able to join
- Full dentition, good general and oral health
Who cannot join
- Facial deformities
- Severe malocclusion
- History of signs and symptoms of temporomandibular disorder
- History of parafunctions
- History of maxillofacial surgery or jaw injuries and orthodontic treatment concluded in the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preferred Chewing Side, Symmetry of Bite Force and Occlusal Contact Area of Subjects With Different Craniofacial Vertical Dimensions
The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of occlusal contact area and bite force of individuals with different craniofacial patterns
Read the detailed description
Dolichofacial subjects presents poorer mechanical advantage, less efficiency in masticatory muscles during mastication and in generating bite force, smaller occlusal contact area and masticatory capacity when compared to brachyfacial individuals.
Wide, bilateral chewing cycles were related to better masticatory performance, however, unilateral chewing was reported to be very common in population, and it has been associated to lateral asymmetry on bite force and occlusal contact area.
It has been reported that dolichofacial subjects need greater muscular effort during mastication when compared to meso and brachyfacial subjects. This may cause functional overloading of weaker masticatory muscles, and may lead to functional asymmetries.
- Conditions
- Facies
- Keywords
- Bite force, Dental occlusion, Face, Mastication, Morphology
- Medical subject headings
- Facies, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brachyfacial | Subjects with a horizontal facial growth pattern | |
| Mesofacial | Subjects with a balanced facial growth pattern | |
| Dolichofacial | Subjects with a vertical facial growth pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory movements during mastication
A jaw tracking device was positioned on subjects face, who were asked to chew an artificial material in their habitual way. Tracings of jaw lateral movements during mastication were analyzed to classify in which side each chewing stroke was taken. If 80 percent or more chewing cycles were classified as left or right, the subjects were considered as unilateral chewer.
Measured: 2 hours
Secondary outcomes (1)
Bite force and occlusal contact area
A strain gauge was positioned on subject's first molar region unilaterally to measure the symmetry of bite force. The individual was asked to bite as hard as possible. The procedure was repeated to the other side, and the bite symmetry of sides was analyzed.
To evaluate symmetry of occlusal contact area, a registration of posterior teeth was performed with the subjects in maximal intercuspal position. The registration was digitalized, discolored, color inverted and adjusted for size to evaluate thickness of registration material using a software.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FaciesStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Simone G Farias Gomes, PhD, Principal investigator, Universidade Federal de PernambucoWilliam Custodio, MS, Study chair, Piracicaba Denal School, State University of CampinasFernanda Faot, PhD, Study chair, Federal University of PelotasAltair A Del Bel Cury, PhD, Study director, Piracicaba Dental School, State University of CampinasRenata CM Rodrigues Garcia, PhD, Study director, Piracicaba Dental School, State University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286363
- Sponsor's protocol ID
- monegfg11
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomes SG, Custodio W, Faot F, Del Bel Cury AA, Garcia RC. Masticatory features, EMG activity and muscle effort of subjects with different facial patterns. J Oral Rehabil. 2010 Nov;37(11):813-9. doi: 10.1111/j.1365-2842.2010.02075.x. Epub 2010 Aug 19.
PubMed 20726943Martinez-Gomis J, Lujan-Climent M, Palau S, Bizar J, Salsench J, Peraire M. Relationship between chewing side preference and handedness and lateral asymmetry of peripheral factors. Arch Oral Biol. 2009 Feb;54(2):101-7. doi: 10.1016/j.archoralbio.2008.09.006. Epub 2008 Oct 22.
PubMed 18947820Garcia-Morales P, Buschang PH, Throckmorton GS, English JD. Maximum bite force, muscle efficiency and mechanical advantage in children with vertical growth patterns. Eur J Orthod. 2003 Jun;25(3):265-72. doi: 10.1093/ejo/25.3.265.
PubMed 12831216Sonnesen L, Bakke M, Solow B. Temporomandibular disorders in relation to craniofacial dimensions, head posture and bite force in children selected for orthodontic treatment. Eur J Orthod. 2001 Apr;23(2):179-92. doi: 10.1093/ejo/23.2.179.
PubMed 11398555Gomes SG, Custodio W, Faot F, Cury AA, Garcia RC. Chewing side, bite force symmetry, and occlusal contact area of subjects with different facial vertical patterns. Braz Oral Res. 2011 Sep-Oct;25(5):446-52. doi: 10.1590/s1806-83242011005000014.
PubMed 22031059
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferred Chewing Side, Symmetry of Bite Force and Occlusal Contact Area of Subjects With Different Craniofacial Vertical Dimensions
- ClinicalTrials.gov ID
- NCT01286363
- Acronym / sponsor ID
- monegfg11
- Conditions
- Facies
- Keywords
- Bite force, Dental occlusion, Face, Mastication, Morphology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Jan 2011 (estimated)
- 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 purpose of this study is to evaluate chewing side preference, and lateral asymmetry of occlusal contact area and bite force of individuals with different craniofacial patterns
Detailed description
Dolichofacial subjects presents poorer mechanical advantage, less efficiency in masticatory muscles during mastication and in generating bite force, smaller occlusal contact area and masticatory capacity when compared to brachyfacial individuals.
Wide, bilateral chewing cycles were related to better masticatory performance, however, unilateral chewing was reported to be very common in population, and it has been associated to lateral asymmetry on bite force and occlusal contact area.
It has been reported that dolichofacial subjects need greater muscular effort during mastication when compared to meso and brachyfacial subjects. This may cause functional overloading of weaker masticatory muscles, and may lead to functional asymmetries.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brachyfacial | – | –Subjects with a horizontal facial growth pattern |
| Mesofacial | – | –Subjects with a balanced facial growth pattern |
| Dolichofacial | – | –Subjects with a vertical facial growth pattern |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students and staff of Piracicaba Dental School, and individuals seeking for dental treatment at the same institution
Key inclusion criteria (1 listed)
- Full dentition, good general and oral health
Key exclusion criteria (5 listed)
- Facial deformities
- Severe malocclusion
- History of signs and symptoms of temporomandibular disorder
- History of parafunctions
- History of maxillofacial surgery or jaw injuries and orthodontic treatment concluded in the last 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Masticatory movements during mastication
Time frame: 2 hours
A jaw tracking device was positioned on subjects face, who were asked to chew an artificial material in their habitual way. Tracings of jaw lateral movements during mastication were analyzed to classify in which side each chewing stroke was taken. If 80 percent or more chewing cycles were classified as left or right, the subjects were considered as unilateral chewer.
1 secondary outcome
Bite force and occlusal contact area
Time frame: 2 hours
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 31 Jan 2011.
- Background: PubMed 20726943Gomes SG, Custodio W, Faot F, Del Bel Cury AA, Garcia RC. Masticatory features, EMG activity and muscle effort of subjects with different facial patterns. J Oral Rehabil. 2010 Nov;37(11):813-9. doi: 10.1111/j.1365-2842.2010.02075.x. Epub 2010 Aug 19.
- Background: PubMed 18947820Martinez-Gomis J, Lujan-Climent M, Palau S, Bizar J, Salsench J, Peraire M. Relationship between chewing side preference and handedness and lateral asymmetry of peripheral factors. Arch Oral Biol. 2009 Feb;54(2):101-7. doi: 10.1016/j.archoralbio.2008.09.006. Epub 2008 Oct 22.
- Background: PubMed 12831216Garcia-Morales P, Buschang PH, Throckmorton GS, English JD. Maximum bite force, muscle efficiency and mechanical advantage in children with vertical growth patterns. Eur J Orthod. 2003 Jun;25(3):265-72. doi: 10.1093/ejo/25.3.265.
- Background: PubMed 11398555Sonnesen L, Bakke M, Solow B. Temporomandibular disorders in relation to craniofacial dimensions, head posture and bite force in children selected for orthodontic treatment. Eur J Orthod. 2001 Apr;23(2):179-92. doi: 10.1093/ejo/23.2.179.
- Derived from this study: PubMed 22031059Gomes SG, Custodio W, Faot F, Cury AA, Garcia RC. Chewing side, bite force symmetry, and occlusal contact area of subjects with different facial vertical patterns. Braz Oral Res. 2011 Sep-Oct;25(5):446-52. doi: 10.1590/s1806-83242011005000014.
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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.
Simone G Farias Gomes, PhD principal investigator
Universidade Federal de Pernambuco
William Custodio, MS study chair
Piracicaba Denal School, State University of Campinas
Fernanda Faot, PhD study chair
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facies, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 5 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 31 Jan 2011. 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 Brazil. 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 movements during mastication (time frame: 2 hours). 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 NCT01286363, which also lists 5 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 31 Jan 2011.