Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

NCT02168374 | Completed Phase 2

• 2 other identifiers: PGICACDFAPESP
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Caries

Keywords

Glass ionomer cement; Indirect pulp therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 3 months

Study Arms (3)

Chlorhexidine - CHX

EXPERIMENTAL

Deciduous teeth were filled with GIC containing 1.25% chlorhexidine.

Other: Indirect pulp treatment

Doxycycline - DOX

EXPERIMENTAL

Deciduous teeth were filled with GIC containing 4.5% doxycycline.

Other: Indirect pulp treatment

Glass ionomer cement - GIC

PLACEBO COMPARATOR

Deciduous teeth were filled with GIC without chlorhexidine or doxycycline.

Other: Indirect pulp treatment

Interventions

Indirect pulp treatment OTHER

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.

Chlorhexidine - CHX; Doxycycline - DOX; Glass ionomer cement - GIC

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• presence of signs of irreversible damage to the pulp
• children presenting systemic disease or those using medications.

Sponsors & Collaborators

• Aline R F de Castilho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (1)

• 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.

  PMID: 23123495 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Aline RF Castilho, PhD

  Piracicaba Dental School, Unicamp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 20, 2014
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2011
• Last Updated: June 23, 2014

Record last verified: 2014-06