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Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Indirect pulp treatment

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Glass ionomer cement, Indirect pulp therapy

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Chlorhexidine - CHX

Doxycycline - DOX

Glass ionomer cement - GIC

Arm Description

Deciduous teeth were filled with GIC containing 1.25% chlorhexidine.

Deciduous teeth were filled with GIC containing 4.5% doxycycline.

Deciduous teeth were filled with GIC without chlorhexidine or doxycycline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02168374

First Posted

June 3, 2014

Last Updated

June 19, 2014

Sponsor

Aline R F de Castilho

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02168374

Brief Title

Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aline R F de Castilho

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Glass ionomer cement, Indirect pulp therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chlorhexidine - CHX

Arm Type

Experimental

Arm Description

Deciduous teeth were filled with GIC containing 1.25% chlorhexidine.

Arm Title

Doxycycline - DOX

Arm Type

Experimental

Arm Description

Deciduous teeth were filled with GIC containing 4.5% doxycycline.

Arm Title

Glass ionomer cement - GIC

Arm Type

Placebo Comparator

Arm Description

Deciduous teeth were filled with GIC without chlorhexidine or doxycycline.

Intervention Type

Other

Intervention Name(s)

Indirect pulp treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.

Description

Within 3 months after the initial treatment, the teeth were submitted to clinical and radiographic examination to determine signs and symptoms of pulp vitality.

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.

Description

Dentine samples were collected at baseline and after 3 months of the treatment for microbiological evaluation (colony-forming unit - CFU).

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aline RF Castilho, PhD

Organizational Affiliation

Piracicaba Dental School, Unicamp

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

23123495

Citation

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.

Results Reference

result

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Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

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