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Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02168374
Enrollment
18
Registered
2014-06-20
Start date
2008-03-31
Completion date
2011-10-31
Last updated
2014-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Glass ionomer cement, Indirect pulp therapy

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.

Interventions

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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Aline R F de Castilho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026