Clinical Investigation of Effectiveness of a Calcium Silicate Cement
NCT ID: NCT06256601
Last Updated: 2024-02-16
Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-07-12
2024-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Theracal (calcium silicate)
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.
Theracal (calcium silicate)
selective removal to soft dentin, restorations with calcium silicate
Dycal (calcium hydroxide)
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.
Dycal (calcium hydroxide)
selective removal to soft dentin, restoration with calcium hydroxide
Interventions
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Theracal (calcium silicate)
selective removal to soft dentin, restorations with calcium silicate
Dycal (calcium hydroxide)
selective removal to soft dentin, restoration with calcium hydroxide
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Betul Kesim
Principal Investigator
Principal Investigators
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Arlin Serpuhi Kiremitci, Prof.
Role: STUDY_DIRECTOR
Hacettepe University
Uzay Koç Vural, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Betül Kesim
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Locations
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Hacettepe University
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Schwendicke F, Walsh T, Lamont T, Al-Yaseen W, Bjorndal L, Clarkson JE, Fontana M, Gomez Rossi J, Gostemeyer G, Levey C, Muller A, Ricketts D, Robertson M, Santamaria RM, Innes NP. Interventions for treating cavitated or dentine carious lesions. Cochrane Database Syst Rev. 2021 Jul 19;7(7):CD013039. doi: 10.1002/14651858.CD013039.pub2.
Figundio N, Lopes P, Tedesco TK, Fernandes JCH, Fernandes GVO, Mello-Moura ACV. Deep Carious Lesions Management with Stepwise, Selective, or Non-Selective Removal in Permanent Dentition: A Systematic Review of Randomized Clinical Trials. Healthcare (Basel). 2023 Aug 18;11(16):2338. doi: 10.3390/healthcare11162338.
Schwendicke, F., in Management of Deep Carious Lesions. 2018, Springer Nature: Gewerbestrasse.
Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276.
Barros MMAF, De Queiroz Rodrigues MI, Muniz FWMG, Rodrigues LKA. Selective, stepwise, or nonselective removal of carious tissue: which technique offers lower risk for the treatment of dental caries in permanent teeth? A systematic review and meta-analysis. Clin Oral Investig. 2020 Feb;24(2):521-532. doi: 10.1007/s00784-019-03114-5. Epub 2019 Nov 26.
Kunert M, Lukomska-Szymanska M. Bio-Inductive Materials in Direct and Indirect Pulp Capping-A Review Article. Materials (Basel). 2020 Mar 7;13(5):1204. doi: 10.3390/ma13051204.
Schmidt J, Buenger L, Krohn S, Kallies R, Zeller K, Schneider H, Ziebolz D, Berg T, Haak R. Effect of a bioactive cement on the microbial community in carious dentin after selective caries removal - An in-vivo study. J Dent. 2020 Jan;92:103264. doi: 10.1016/j.jdent.2019.103264. Epub 2019 Dec 13.
Koc Vural U, Kiremitci A, Gokalp S. Which is the most effective biomaterial in indirect pulp capping? 4- year comparative randomized clinical trial. Eur Oral Res. 2022 Jan 1;56(1):35-41. doi: 10.26650/eor.2022895748.
Edwards D, Stone S, Bailey O, Tomson P. Preserving pulp vitality: part one - strategies for managing deep caries in permanent teeth. Br Dent J. 2021 Jan;230(2):77-82. doi: 10.1038/s41415-020-2590-7. Epub 2021 Jan 22.
Jurasic MM, Gillespie S, Sorbara P, Clarkson J, Ramsay C, Nyongesa D, McEdward D, Gilbert GH, Vollmer WM; National Dental PBRN Collaborative Group. Deep caries removal strategies: Findings from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2022 Nov;153(11):1078-1088.e7. doi: 10.1016/j.adaj.2022.08.005. Epub 2022 Sep 26.
Other Identifiers
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KA-23024
Identifier Type: -
Identifier Source: org_study_id
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