Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Other: Indirect pulp treatment

• Registration Number: NCT02168374
• Lead Sponsor: Aline R F de Castilho

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-03
• Study Completion: 2011-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-17
• Last Update Submitted: 2014-06-19
• Study First Posted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine - CHX	Indirect pulp treatment	Deciduous teeth were filled with GIC containing 1.25% chlorhexidine.
Doxycycline - DOX	Indirect pulp treatment	Deciduous teeth were filled with GIC containing 4.5% doxycycline.
Glass ionomer cement - GIC	Indirect pulp treatment	Deciduous teeth were filled with GIC without chlorhexidine or doxycycline.

Primary Outcome Measures

Name	Time	Method
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.	up to 3 months	Within 3 months after the initial treatment, the teeth were submitted to clinical and radiographic examination to determine signs and symptoms of pulp vitality.

Secondary Outcome Measures

Name	Time	Method
Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.	up to 3 months	Dentine samples were collected at baseline and after 3 months of the treatment for microbiological evaluation (colony-forming unit - CFU).