Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

Dental Caries Clinical Trial

Official title:

Biological and Physicomechanical Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168374
• Other study ID #: PGICACD
• Secondary ID: FAPESP
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2014
• Last updated: June 19, 2014
• Start date: March 2008
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

This study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.

Description:

This study aimed to evaluate the in vivo microbiologic action of the best concentration of chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied on remaining dentine after indirect pulp treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• an active deep carious lesion at the internal half of the dentine thickness of a primary molar that had not been previously restored and that involved the occlusal or occlusoproximal surface;

• the absence of signs of irreversible damage to the pulp

• the absence of radiolucencies at the interradicular or periapical region or thickening of the periodontal spaces, absence of internal and external root resorption, absence of calcification of the pulp tissue

• children presenting no systemic disease or those not using medications.

Exclusion Criteria:

• presence of signs of irreversible damage to the pulp

• children presenting systemic disease or those using medications.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Indirect pulp treatment
Carious dentine was sampled from the mesial portion of the cavity floor and the pulpal wall was entirely covered with one of the randomly selected materials: GIC containing 4.5% DOX; GIC containing 1.25% CHX or GIC as a control group. The antimicrobial concentrations were chosen based in the previous in vitro results obtained in this study. The cavities were then temporarily restored using a conventional GIC. Within 3 months after the initial treatment,the materials were carefully and completely removed, a new dentine sample was collected, and the teeth were then restored with a light-cured composite resin using a bonding system, after a new placement of the initial liner material.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aline R F de Castilho	Fundação de Amparo à Pesquisa do Estado de São Paulo

References & Publications (1)

de Castilho AR, Duque C, Negrini Tde C, Sacono NT, de Paula AB, de Souza Costa CA, Spolidório DM, Puppin-Rontani RM. In vitro and in vivo investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.	Within 3 months after the initial treatment, the teeth were submitted to clinical and radiographic examination to determine signs and symptoms of pulp vitality.	up to 3 months	Yes
Secondary	Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.	Dentine samples were collected at baseline and after 3 months of the treatment for microbiological evaluation (colony-forming unit - CFU).	up to 3 months	Yes