Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Indirect pulp treatment

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine - CHX; Deciduous teeth were filled with GIC containing 1.25% chlorhexidine.	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.
Experimental: Doxycycline - DOX; Deciduous teeth were filled with GIC containing 4.5% doxycycline.	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.
Placebo Comparator: Glass ionomer cement - GIC; Deciduous teeth were filled with GIC without chlorhexidine or doxycycline.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aline R F de Castilho
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Aline RF Castilho, PhD, Piracicaba Dental School, Unicamp

Publications and helpful links

General Publications

• de Castilho AR, Duque C, Negrini Tde C, Sacono NT, de Paula AB, de Souza Costa CA, Spolidorio DM, Puppin-Rontani RM. In vitro and in vivo investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexidine. J Dent. 2013 Feb;41(2):155-63. doi: 10.1016/j.jdent.2012.10.014. Epub 2012 Oct 30.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Glass ionomer cement; Indirect pulp therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PGICACD; FAPESP (Other Grant/Funding Number: 2010/50120-4)