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

NCT ID: NCT01819350

Last Updated: 2013-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-08-31

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.

Conditions

Dental Biofilm pH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

G4 and G5

Application of antibiotic group of pediatric medicines and control group (sucrose 10 %)on dental biofilm.

Group Type: EXPERIMENTAL

G4 and G5

Intervention Type: OTHER

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

G1, G2 and G3

Application of Nutritional, Respiratory and Endocrine groups medicines pediatric on dental biofilm

Group Type: EXPERIMENTAL

G1, G2 and G3

Intervention Type: OTHER

Nutritional, respiratory and endocrine group applicated 12 subjects

Interventions

G1, G2 and G3

Nutritional, respiratory and endocrine group applicated 12 subjects

Intervention Type: OTHER

G4 and G5

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Fabio Correia Sampaio

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Paraíba

João Pessoa, Paraíba, Brazil

Countries

Brazil

Other Identifiers

SOPM-UFPB

Identifier Type: -

Identifier Source: org_study_id