Food ComminutionSOFNCT01020084
Salivary Flow Rate and Oral Function
An observational study of Food Comminution and Jaw Movements, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions. Read more about this study
- Who is it for?
- Ages 16 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Comminution, Jaw Movements
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Nov 2007
- 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 16 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Forty subjects were selected (20 male and 20 female) among people seeking for dental treatment, students and staff of Piracicaba Dental School.Saliva collection was performed for all subjects, and indivuduals with normal salivary flow rate composed the control group. Hyposalivation group group, otherwise, was composed by subjects taking 0.5-0.7 mg/kg/day for at least one month prescribed by a dermatologist.
Who may be able to join
- Fully dentate
- Good general and oral health
Who cannot join
- Signs or symptoms of temporomandibular disorders
- Parafunctions
- Malocclusion
- History of communication deficits or prior speech-language treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hyposalivation on Mastication and Speech
The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.
Read the detailed description
Hyposalivation may damage oral functions. Therefore, the aim of this study was to evaluate whether patients under hyposalivation present damaged mastication and speech. Forty subjects composed 2 groups: Control (C) and hyposalivation (H). Masticatory performance (MP) was carried out using artificial material and a 10-sieve method. Mandibular movements during speech were obtained using a 3D jaw-tracking device. Neither mastication nor speech have been impaired by low salivary flow rate.
- Conditions
- Food Comminution, Jaw Movements
- Keywords
- Saliva, Mastication, Communication
- Medical subject headings
- Communication
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 |
|---|---|---|
| Control | Subjects with normal salivary flow rate | |
| Hyposalivation | Subjects presenting low salivary flow rate as a side effect of systemic isotretinoin therapy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startAug 2006
- Primary completionAug 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food ComminutionStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Renata CM Rodrigues Garcia, PhD, Study chair, Piracicaba Dental SchoolAlrair A Del Bel Cury, PhD, Study director, Piracicaba Dental SchoolSimone G Farias Gomes, MS, Principal investigator, Piracicaba Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020084
- Sponsor's protocol ID
- monegfg09
- Acronym
- SOF
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Saliva: its role in health and disease. Working Group 10 of the Commission on Oral Health, Research and Epidemiology (CORE). Int Dent J. 1992 Aug;42(4 Suppl 2):287-304. No abstract available.
PubMed 1399047Bianchini EM, de Andrade CR. A model of mandibular movements during speech: normative pilot study for the Brazilian Portuguese language. Cranio. 2006 Jul;24(3):197-206. doi: 10.1179/crn.2006.032.
PubMed 16933461Liedberg B, Owall B. Masticatory ability in experimentally induced xerostomia. Dysphagia. 1991;6(4):211-3. doi: 10.1007/BF02493529.
PubMed 1778098Ishijima T, Koshino H, Hirai T, Takasaki H. The relationship between salivary secretion rate and masticatory efficiency. J Oral Rehabil. 2004 Jan;31(1):3-6. doi: 10.1111/j.1365-2842.2004.01033.x.
PubMed 15125589
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyposalivation on Mastication and Speech
- ClinicalTrials.gov ID
- NCT01020084
- Acronym / sponsor ID
- SOF / monegfg09
- Conditions
- Food Comminution, Jaw Movements
- Keywords
- Saliva, Mastication, Communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Nov 2009 (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 was to investigate if salivary flow rate is important to maintain adequate oral functions.
Detailed description
Hyposalivation may damage oral functions. Therefore, the aim of this study was to evaluate whether patients under hyposalivation present damaged mastication and speech. Forty subjects composed 2 groups: Control (C) and hyposalivation (H). Masticatory performance (MP) was carried out using artificial material and a 10-sieve method. Mandibular movements during speech were obtained using a 3D jaw-tracking device. Neither mastication nor speech have been impaired by low salivary flow rate.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Subjects with normal salivary flow rate |
| Hyposalivation | – | –Subjects presenting low salivary flow rate as a side effect of systemic isotretinoin therapy. |
Who may qualify
- Ages
- 16 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Forty subjects were selected (20 male and 20 female) among people seeking for dental treatment, students and staff of Piracicaba Dental School.Saliva collection was performed for all subjects, and indivuduals with normal salivary flow rate composed the control group. Hyposalivation group group, otherwise, was composed by subjects taking 0.5-0.7 mg/kg/day for at least one month prescribed by a dermatologist.
Key inclusion criteria (2 listed)
- Fully dentate
- Good general and oral health
Key exclusion criteria (4 listed)
- Signs or symptoms of temporomandibular disorders
- Parafunctions
- Malocclusion
- History of communication deficits or prior speech-language treatment
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
Not reported in the source record.
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 25 Nov 2009.
- Background: PubMed 1399047Saliva: its role in health and disease. Working Group 10 of the Commission on Oral Health, Research and Epidemiology (CORE). Int Dent J. 1992 Aug;42(4 Suppl 2):287-304. No abstract available.
- Background: PubMed 16933461Bianchini EM, de Andrade CR. A model of mandibular movements during speech: normative pilot study for the Brazilian Portuguese language. Cranio. 2006 Jul;24(3):197-206. doi: 10.1179/crn.2006.032.
- Results publication: PubMed 1778098Liedberg B, Owall B. Masticatory ability in experimentally induced xerostomia. Dysphagia. 1991;6(4):211-3. doi: 10.1007/BF02493529.
- Results publication: PubMed 15125589Ishijima T, Koshino H, Hirai T, Takasaki H. The relationship between salivary secretion rate and masticatory efficiency. J Oral Rehabil. 2004 Jan;31(1):3-6. doi: 10.1111/j.1365-2842.2004.01033.x.
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.
Renata CM Rodrigues Garcia, PhD study chair
Piracicaba Dental School
Alrair A Del Bel Cury, PhD study director
Piracicaba Dental School
Simone G Farias Gomes, MS principal investigator
Piracicaba Dental School
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 Food Comminution and Jaw Movements, 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 2 inclusion and 4 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 25 Nov 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020084, which also lists 4 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 25 Nov 2009.