The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping

Study Overview
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Brief Summary
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The purpose of this randomized clinical study was to evaluate the efficiency of Er,Cr:YSGG laser irradiation combined with a resin based tricalcium silicate material and calcium hydroxide (CH) in direct pulp capping for 3 months follow-up period.Sixty permanent vital teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15): Gr 1: The exposed area was sealed with CH paste, Gr 2: The treated area was sealed with CH paste following Er,Cr:YSGG laser irradiation at an energy level of 0,5 W without water and 45% air, Gr 3: Resin based tricalcium silicate material (TheraCal LC) was applied directly to the exposed pulp, Gr 4: TheraCal LC was applied following irradiation with Er,Cr:YSGG laser.

Detailed Description
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CH is used as gold standard in pulp capping procedures due to its beneficial properties such as induction of mineralization and inhibition of bacterial growth; however tunnel defects and cell inclusions in dentin bridges formed by CH may lead to leakage and bacteria penetration resulting in loss of vitality. TheraCal LC is a new light-cured, resin-modified, tricalcium silicate based material designed to use for direct and indirect pulp-capping aiming to achieve a bond to composite resins thus reducing micro-leakage.The formulation of TheraCal LC containing tricalcium silicate particles in a hydrophilic monomer provides significant calcium release that stimulates hydroxyapatite and secondary dentin bridge formation The use of laser for direct pulp capping has been suggested for the considerable advantages of lasers including decontamination effect, biostimulation effect, hemostatic and coagulant effect.The erbium, chromium-doped:yttrium, scandium, gallium and garnet (Er,Cr:YSGG) laser which is a relatively new device has been reported to ablate dental hard tissues thanks to its high absorption in water and also strong absorption by the hydroxyl radicals present in the hydroxyapatite structure

Official Title
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Efficacy of Er,Cr:YSGG Laser Irradiation Combined With Resin Based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: a Randomized Clinical Trial

Conditions
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Dental Pulp Exposure

Intervention / Treatment
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* Other: Calcium Hydroxide
* Other: Er,Cr:YSGG laser + calcium hydroxide
* Other: TheraCal LC
* Other: Er,Cr:YSGG laser + TheraCal LC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent teeth with deep caries without symptoms Vital teeth No periapical radiographic changes The diameter of the exposed area is between 0,5 mm to 1,5 mm Exclusion Criteria: Spontaneous pain, Tenderness to percussion and palpation, Bleeding lasting over 3 minute after exposure, Periapical radiographic changes such as periradicular or furcal radiolucency, a widened periodontal ligament space and resorption.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium hydroxide<br>Direct pulp capping with a self-hardening calcium hydroxide paste | Other: Calcium Hydroxide<br>* Exposed area was sealed with a self-hardening calcium hydroxide paste then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin<br>* Other names: Dycal, Dentsply, Tulsa, OK, USA;|
| Experimental: Er,Cr:YSGG laser + calcium hydroxide<br>Direct pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide | Other: Er,Cr:YSGG laser + calcium hydroxide<br>* After the exposed area was irradiated with Er,Cr:YSGG laser at an energy level of 0,5 W, a repetition rate of 20 Hz, 140 µs pulse duration with 0% water and 45% air for 10 s, it was sealed with a self-hardening calcium hydroxide paste.Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin<br>* Other names: Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA);|
| Experimental: TheraCal LC<br>Direct pulp capping with resin based tricalcium silicate material | Other: TheraCal LC<br>* TheraCal LC was applied directly to the exposed pulp with a needle tip syringe in incremental layers that was not to exceed 1 mm in depth. Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin<br>* Other names: TheraCal LC, Bisco, Schaumburg, Illinois, USA;|
| Experimental: Er,Cr:YSGG laser + TheraCal LC<br>Direct pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material | Other: Er,Cr:YSGG laser + TheraCal LC<br>* After the exposed area was irradiated with Er,Cr:YSGG laser at an energy level of 0,5 W, a repetition rate of 20 Hz, 140 µs pulse duration with 0% water and 45% air for 10 s, TheraCal LC was used to seal the treated area. Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulp vitality | Pulp vitality is assessed with electric pulp tester as vital or non-vital | 3 months | 
| Assessment of pain with questionnaire | Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. No reactions to thermal stimuli and no tenderness to percussion. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success | No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, no widened periodontal ligament space | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct pulp capping, Er,Cr:YSGG laser, Tricalcium silicate