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Clinical Trials/NCT01819350
NCT01819350CompletedPhase 2

Avaliação in Vivo do Potencial cariogênico e Erosivo de Bebidas e Medicamentos pediátricos líquidos Intra-orais

Federal University of Paraíba2 sites in 1 country12 target enrollmentStarted: August 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH

Study Overview

Brief Summary

The aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm pH to evaluate the cariogenic potential in vivo.

Detailed Description

Te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. Dental biofilm pH was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. The biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 22 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 18 to 22 years;
  • Having Oral hygiene adequate (OHI<1.1);
  • Having 20 natural teeth incluing molar;
  • Not havind oral disease.

Exclusion Criteria

  • Biofilm baseline pH > 5,5;
  • Not signature consent term;
  • Using orthodontic appliance;
  • Having used medicines last 3 months;
  • Pregant woman.

Outcomes

Primary Outcomes

Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH

Time Frame: 6 months

pH was measured in the cervical and proximal regions of anterior teeth dental biofilm with beetrode-type microelectrode coupled to a potentiometer

Secondary Outcomes

  • Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm(12 months)

Investigators

Sponsor
Federal University of Paraíba
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fabio Correia Sampaio

PhD

Federal University of Paraíba

Study Sites (2)

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