Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

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

Detailed Description
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Indirect pulp treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine - CHX<br>Deciduous teeth were filled with GIC containing 1.25% chlorhexidine. | Other: Indirect pulp treatment<br>* 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.<br>|
| Experimental: Doxycycline - DOX<br>Deciduous teeth were filled with GIC containing 4.5% doxycycline. | Other: Indirect pulp treatment<br>* 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.<br>|
| Placebo Comparator: Glass ionomer cement - GIC<br>Deciduous teeth were filled with GIC without chlorhexidine or doxycycline. | Other: Indirect pulp treatment<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glass ionomer cement, Indirect pulp therapy