Salivary Flow Rate and Oral Function (SOF)

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. Identifier: NCT01020084
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil

Brief Summary:
The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.

Condition or disease
Food Comminution Jaw Movements

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 Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Cross-Sectional
Official Title: Effect of Hyposalivation on Mastication and Speech
Study Start Date : August 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : November 2007

Subjects with normal salivary flow rate
Subjects presenting low salivary flow rate as a side effect of systemic isotretinoin therapy.

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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.

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

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 identifier (NCT number): 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