Clinical Investigation of Effectiveness of a Calcium Silicate Cement

Hacettepe University

Status: Enrolling

Conditions: Dentin Caries; Deep Caries

Treatments: Device: Theracal (calcium silicate); Device: Dycal (calcium hydroxide)

Study type: Interventional

Funder types: Other

Identifiers

NCT06256601

KA-23024

Details and patient eligibility

About

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.

Full description

This clinical study aims to investigate the 18-month clinical performance of calcium silicate and calcium hydroxide materials used in the treatment of deep caries lesions.

Material and Methods: Eighty patients who applied to the Restorative Dentistry Clinic of Hacettepe University Faculty of Dentistry, aged between 18-45 years, will be recruited for the study. Patients to be included must have at least one deep dentin caries (D3). For standardization purposes, one researcher will carry out the interventional procedures. Before interventions, any attachments on the teeth will be removed using pumice and polishing rubbers. Restorations will be carried out under rubber dam isolation (OptraDam, Liechtenstein). If the patient experiences any pain, anesthesia will be applied. Dentinal carious lesions will be accessed by the removal of surrounding unsupported enamel with a round diamond bur at high speed under water cooling. Carious tissue in the pulpal aspect of the cavity will be excavated by hand instruments to soft dentin. Only disorganized dentine will be removed. A reasonable amount of soft carious tissue will be left over the pulp. The procedure will be carried out considering the risk of exposing the pulp tissue. In the test group a Calcium silicate, (TheraCal LC, Bisco, Schaumburg, IL, USA), and in the control group a calcium hydroxide (Dycal, Dentsply, Caulk, Milford, DE, USA) materials will be applied to the pulpal floor following the instructions of the manufacturer. Then, these materials in both groups will be sealed by resin-modified glass ionomer cement (SDI, Bayswater, Australia).

Selective etching with 37% phosphoric acid (Total Etch-Ivoclar/Vivadent, Liechtenstein) will be applied for 10 s in enamel. Cavities will be rinsed for 10 s, and adhesive material (G-Premio-bond, GC Europe, Leuven, Belgium) will be applied with a micro brush in cavity walls with rubbing for 20 s. After gentle air drying for approximately 5 s, a 1200 W/cm2 intensity LED light device) will be used for 10 s light curing. For the restoration of Class II cavities, a sectional matrix (Palodent V3, Dentsply Sirona, York/Pennsylvania, USA) will be placed. Then, permanent restoration with a posterior composite resin (Gradia Direct Posterior, GC, GC Coop., Tokyo, Japan) will be carried out at the same session. Evaluations will be conducted by two independent researchers after 6, 12, and 18 months according to FDI criteria.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The age of the patient should be ranged between 18-45.
• The score of the caries lesion should be D3.
• Absence of a history of spontaneous pain in the teeth to be included.
• Absence of periapical pathology
• No displacement or mobility of the teeth.
• Caries should not have reached the pulp tissue, and there should be no root fractures.
• Restorable by direct restoration and functional

Exclusion criteria

• Poor oral hygiene of the participant.
• Parafunctional habits such as teeth clenching or grinding.
• Caries extending to the underneath of gingival margin
• Severe periodontal pathology
• Previous restored teeth
• Teeth undergoing orthodontic treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Theracal (calcium silicate)

Experimental group

Description:

TheraCal LC is a light-cured resin-modified calcium silicate pulp protectant/liner designed to perform as a barrier and to protect the dental pulpal complex. It contains; resin bis-phenyl glycidyl methacrylate (BisGMA) \& polyethylene glycol dimethacrylate (PEGD), modified calcium silicated with CaO, calcium silicate particles (type III Portland cement), Sr glass, fumed silica, barium sulphate, barium zirconate. After caries removal, TheraCal is applied directly to the cavity floor in incremental layers. The layer is not to exceed 1 mm in depth. Each layer polymerized for 20 seconds.

Treatment:

Device: Theracal (calcium silicate)

Dycal (calcium hydroxide)

Active Comparator group

Description:

Dycal,Calcium Hydroxide Liner is a two-component, rigid-setting, self-curing material designed for use in direct and indirect pulp capping and as a protective liner under dental adhesives, varnishes, filling materials, cements, and other base materials. It will not inhibit the polymerization of acrylic and composite restorations. Dycal, a two-paste system made of a base paste (1,3-butylene glycol disalicylate, zinc oxide, calcium phosphate, calcium tungstate, iron oxide pigments) and a catalyst paste (calcium hydroxide, N-ethyl-o/p-toluene sulphonamide, zinc oxide, titanium oxide, zinc stearate, iron oxide pigments) is prepared following the manufacturer's instructions by mixing equal amounts of catalyst paste and base paste. After caries removal, Dycal is applied directly to the cavity floor, material thickness should be approximately 0.8mm-1mm. The mixed material will set in approximately 2-3 minutes.

Treatment:

Device: Dycal (calcium hydroxide)