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

Dental Biofilm pH Clinical Trial

— SPMedicines  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819350
• Other study ID #: SOPM-UFPB
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2013
• Last updated: March 24, 2013
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2013
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Health Nacional Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 22 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Biofilm pH

Intervention

Other:
• G1, G2 and G3
Nutritional, respiratory and endocrine group applicated 12 subjects
• G4 and G5
Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of group respiratory, nutritional and endocrine pediatric medicines effect on dental biofilm pH	pH was measured in the cervical and proximal regions of anterior teeth dental biofilm with beetrode-type microelectrode coupled to a potentiometer	6 months	Yes
Secondary	Evaluation of sucrose antibiotic group and control negative group effect on dental biofilm	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	Yes