NCT01020084

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

November 24, 2009

Last Update Submit

November 24, 2009

Conditions

Food ComminutionJaw Movements

Keywords

SalivaMasticationCommunication

Study Arms (2)

Control

Subjects with normal salivary flow rate

Hyposalivation

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

Eligibility Criteria

Age16 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Fully dentate
  • Good general and oral health

You may not qualify if:

  • Signs or symptoms of temporomandibular disorders
  • Parafunctions
  • Malocclusion
  • History of communication deficits or prior speech-language treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 1399047BACKGROUND

  • Bianchini 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.

    PMID: 16933461BACKGROUND

  • Liedberg B, Owall B. Masticatory ability in experimentally induced xerostomia. Dysphagia. 1991;6(4):211-3. doi: 10.1007/BF02493529.

    PMID: 1778098RESULT

  • Ishijima 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.

    PMID: 15125589RESULT

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Renata CM Rodrigues Garcia, PhD

    Piracicaba Dental School

    STUDY CHAIR

  • Alrair A Del Bel Cury, PhD

    Piracicaba Dental School

    STUDY DIRECTOR

  • Simone G Farias Gomes, MS

    Piracicaba Dental School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

August 1, 2006

Primary Completion

August 1, 2006

Study Completion

November 1, 2007

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

BR(1)