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

Not Applicable

Completed

• Conditions: Dental Pulp Exposure
• Interventions: Other: Calcium Hydroxide; Other: TheraCal LC

• Registration Number: NCT02487329
• Lead Sponsor: Near East University, Turkey

Brief Summary

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

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

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-26
• Last Update Submitted: 2015-06-26
• Study First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium hydroxide	Calcium Hydroxide	Direct pulp capping with a self-hardening calcium hydroxide paste
TheraCal LC	TheraCal LC	Direct pulp capping with resin based tricalcium silicate material

Primary Outcome Measures

Name	Time	Method
Assessment of pain with questionnaire	3 months	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.
Pulp vitality	3 months	Pulp vitality is assessed with electric pulp tester as vital or non-vital

Secondary Outcome Measures

Name	Time	Method
Radiographic success	3 months	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