In Vivo Study of Sucrose and Liquid Oral Pediatric Medicines of Long-term Effect on Dental Biofilm pH (SPMedicines)

March 24, 2013 updated by: Fabio Correia Sampaio, Federal University of Paraíba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58051900
        • Federal University of Paraíba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G4 and G5
Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm.
Other: G4 and G5
Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects
Experimental: G1, G2 and G3
Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm
Other: G1, G2 and G3
Nutritional, respiratory and endocrine group applicated 12 subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm
Time Frame: 12 months
The biofilm was submitted antibiotic group and negative control group. pH measurements were taken at baseline to determine resting plaque pH and at time interval 5, 10, 15, 20, 25 and 30 minutes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 24, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 24, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOPM-UFPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe