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Salivary Flow Rate and Oral Function (SOF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020084
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
  Purpose
The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.

Condition
Food Comminution Jaw Movements

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Effect of Hyposalivation on Mastication and Speech

Further study details as provided by University of Campinas, Brazil:

Enrollment: 40
Study Start Date: August 2006
Study Completion Date: November 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Subjects with normal salivary flow rate
Hyposalivation
Subjects presenting low salivary flow rate as a side effect of systemic isotretinoin therapy.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 27 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Fully dentate
  • Good general and oral health

Exclusion Criteria:

  • Signs or symptoms of temporomandibular disorders
  • Parafunctions
  • Malocclusion
  • History of communication deficits or prior speech-language treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020084


Locations
Brazil
Piracicaba Dental School
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Renata CM Rodrigues Garcia, PhD Piracicaba Dental School
Study Director: Alrair A Del Bel Cury, PhD Piracicaba Dental School
Principal Investigator: Simone G Farias Gomes, MS Piracicaba Dental School