Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256601
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-05
Brief Title:
Clinical Investigation of Effectiveness of a Calcium Silicate Cement
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
A Clinical Investigation of the Effectiveness of a Calcium Silicate Cement Used in the Treatment of Deep Lesions
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 controlcalcium 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
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 controlcalcium 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-IvoclarVivadent 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 Wcm2 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 YorkPennsylvania 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
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-IvoclarVivadent 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 Wcm2 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 YorkPennsylvania 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None