An interventional study of Theracal (calcium silicate) and Dycal (calcium hydroxide) in Deep Caries and Dentin Caries, sponsored by Hacettepe University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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.
Device: Theracal (calcium silicate)
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.
Device: Dycal (calcium hydroxide)
selective removal to soft dentin, restorations with calcium silicate
selective removal to soft dentin, restoration with calcium hydroxide
Fracture of restorative material and retention
Observers evaluated the restorations was performed using FDI criteria regarding fracture of restorative material and retention. Fracture of restorative material and retention was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Restoration retained, no fractures, cracks or chipping 2: Small hairline crack 3: Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact) 4: Chipping fractures affect marginal quality and/or proximal contacts; bulk fractures with or without partial loss of (\<1/2 of the restoration) 5: (Partial or complete) loss of the restoration
Time frame: From Baseline to 12 Month
Postoperative sensitivity and tooth vitality
Observers evaluated the restorations was performed using FDI criteria regarding postoperative sensitivity and tooth vitality. Postoperative sensitivity and tooth vitality was evaluated by 2 independent clinicians. Scores; 1: No hypersensitivity, normal vitality 2: Low hypersensitivity for a limited period of time, normal vitality 3: Premature/slightly more intense or delayed/weak hypersensitivity. No subjective complaints 4:Premature/very intense or extremely delayed/weak hypersensitivity with subjective complaints. Or negative sensitivity 5: Very intense, acute pulpitis or non vital tooth. Removal of restoration with or without immediate root canal treatment is required or the tooth must be extracted
Time frame: From Baseline to 12 Month
Recurrence of initial pathology (secondary caries)
Observers evaluated the restorations was performed using FDI criteria regarding recurrence of initial pathology (secondary caries). Recurrence of initial pathology (secondary caries) was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No secondary or primary caries 2: Very small, localized demineralization area 3: Larger areas of demineralisation, preventive measures necessary (dentine not exposed) 4: Caries with cavitation 5: Deep secondary caries or exposed dentine that is not accessible for repair
Time frame: From Baseline to 12 Month
Tooth cracks and fractures
Observers evaluated the restorations was performed using FDI criteria regarding tooth cracks and fractures. Tooth cracks and fractures was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Complete integrity 2: Minor marginal crack or a hairline crack which cannot be probed. The patient has no clinical symptoms 3: Enamel split or crack \<250 μm. No adverse effects 4: Major enamel split (gap \>250 μm or dentine/base exposed. Or crack\>250 μm (explorer penetrates) 5: Cusp or tooth fracture
Time frame: From Baseline to 12 Month
Localised reactions of soft tissue
Observers evaluated the restorations was performed using FDI criteria regarding localised reactions of soft tissue. Localised reactions of soft tissue in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: Healthy mucosa adjacent to restoration 2: Healthy after minor removal of mechanical irritations (sharp edges etc.) 3: Alteration of mucosa but no suspicion of causal relationship with filling material 4: Suspected mild allergic, lichenoid or toxicological reaction 5: Suspected severe allergic, lichenoid or toxicological reaction
Time frame: [Time Frame: From Baseline to 12 Month]
Oral and somatic/ psychiatric symptoms
Observers evaluated the restorations was performed using FDI criteria regarding oral and somatic/ psychiatric symptoms. Oral and somatic/ psychiatric symptoms in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: No symptoms of adverse effects 2: Short-term minor transient symptoms 3: Minor oral and/or general symptoms of malaise 4: Persistent oral/general symptoms, recurrent symptoms 5: Acute/severe oral/general symptoms requires immediate replacement
Time frame: [Time Frame: From Baseline to 12 Month]
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Hacettepe University