Clinical Investigation of Effectiveness of a Calcium Silicate Cement

NCT06256601 | Recruiting

• 1 other identifier: KA-23024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Caries; Dentin Caries

Keywords

deep dentin caries; calcium silicate; calcium hydroxide; selective caries removal; randomized clinical trial

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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: 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: From Baseline to 12 Month]

Study Arms (2)

Theracal (calcium silicate)

EXPERIMENTAL

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)

ACTIVE COMPARATOR

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)

Interventions

Theracal (calcium silicate) DEVICE

selective removal to soft dentin, restorations with calcium silicate

Theracal (calcium silicate)

Dycal (calcium hydroxide) DEVICE

selective removal to soft dentin, restoration with calcium hydroxide

Dycal (calcium hydroxide)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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.

  PMID: 34280957 BACKGROUND

• 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.

  PMID: 37628535 BACKGROUND

• Schwendicke, F., in Management of Deep Carious Lesions. 2018, Springer Nature: Gewerbestrasse.

  BACKGROUND

• 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.

  PMID: 27099357 BACKGROUND

• 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.

  PMID: 31773371 BACKGROUND

• 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.

  PMID: 32155997 BACKGROUND

• 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.

  PMID: 31843419 BACKGROUND

• 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.

  PMID: 35478709 BACKGROUND

• 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.

  PMID: 33483661 BACKGROUND

• 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.

  PMID: 36175201 BACKGROUND

Study Officials

• Arlin Serpuhi Kiremitci, Prof.

  Hacettepe University

  STUDY DIRECTOR

• Uzay Koç Vural, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Betül Kesim

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül Kesim

CONTACT

+009005445768716; bethulkesim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: July 12, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

TU (1)