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Salivary Flow Rate and Oral Function (SOF)

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil Identifier:
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.

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)
Subjects with normal salivary flow rate
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.

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.

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
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Please refer to this study by its identifier: NCT01020084

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
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