Clinical trial NCT06256601: Clinical Investigation of Effectiveness of a Calcium Silicate Cement
Official title: A Clinical Investigation of the Effectiveness of a Calcium Silicate Cement Used in the Treatment of Deep Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Caries
Dentin Caries
Keywords: deep dentin caries
calcium silicate
calcium hydroxide
selective caries removal
randomized clinical trial
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fracture of restorative material and retention
timeFrame: From Baseline to 12 Month
measure: Postoperative sensitivity and tooth vitality
timeFrame: From Baseline to 12 Month
measure: Recurrence of initial pathology (secondary caries)
timeFrame: From Baseline to 12 Month
measure: Tooth cracks and fractures
timeFrame: From Baseline to 12 Month
measure: Localised reactions of soft tissue
timeFrame: [Time Frame: From Baseline to 12 Month]
measure: Oral and somatic/ psychiatric symptoms
timeFrame: [Time Frame: From Baseline to 12 Month]
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Arlin Serpuhi Kiremitci, Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Uzay Koç Vural, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Betül Kesim
role: PRINCIPAL_INVESTIGATOR
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