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

Phase 2

Completed

• Conditions: Dental Biofilm pH
• Interventions: Other: G4 and G5; Other: G1, G2 and G3

• Registration Number: NCT01819350
• Lead Sponsor: Federal University of Paraíba

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2012-08
• Status Verified: 2013-03
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-24
• Last Update Submitted: 2013-03-24
• Study First Posted: 2013-03-27
• Last Update Posted: 2013-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G4 and G5	G4 and G5	Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm.
G1, G2 and G3	G1, G2 and G3	Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm

Primary Outcome Measures

Name	Time	Method
Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH	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 Outcome Measures

Name	Time	Method
Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm	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.

Trial Locations

Locations (1)

Federal University of Paraíba; 🇧🇷 João Pessoa, Paraíba, Brazil