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Clinical Investigation of Effectiveness of a Calcium Silicate Cement

NCT06256601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-16

No results posted yet for this study

Summary

The aim of this clinical study is to investigate the clinical performance of a calcium silicate used in the treatment of deep caries lesions. Individuals participating in the research will be selected from patients with at least one deep dentin caries (D3) who apply to the Restorative Dentistry Clinic of Hacettepe University Faculty of Dentistry. The age range will be range 18-45.

The teeth to be restored will be evaluated clinically and radiographically. A rubber dam will be used during the treatment. After the removal of enamel, carious tissue at the lateral walls of cavities will be removed to hard dentin using round and single-use round steel burs operating at low speed in all groups. A reasonable amount of soft carious tissue will be left over the pulp.

In test (Calcium silicate) and control(calcium hydroxide) groups, after caries removal, respective material will be applied on the pulpal floor. Then, materials will be sealed by resin-modified glass ionomer cement and permanent restoration will be performed. Evaluation will be conducted after 6, 12, and 18 months.

Conditions

  • Deep Caries
  • Dentin Caries

Interventions

DEVICE

Theracal (calcium silicate)

selective removal to soft dentin, restorations with calcium silicate

DEVICE

Dycal (calcium hydroxide)

selective removal to soft dentin, restoration with calcium hydroxide

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Arlin Serpuhi Kiremitci, Prof. · Hacettepe University

  • Uzay Koç Vural, Assoc. Prof. · Hacettepe University

  • Betül Kesim · Hacettepe University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256601 on ClinicalTrials.gov