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Completed

NCT Number: NCT01819350

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

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.

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Key information

Conditions

Dental Biofilm pH Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Paraíba

João Pessoa, Paraíba, 58051900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

G1, G2 and G3

Other

Nutritional, respiratory and endocrine group applicated 12 subjects

G4 and G5

Other

Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Acronym: SPMedicines

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2013
Registry last updated
Mar 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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