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

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ClinicalTrials.gov Identifier: NCT02487329
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Esra Cengiz, 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.

Condition or disease Intervention/treatment Phase
Dental Pulp Exposure Other: Calcium Hydroxide Other: Er,Cr:YSGG laser + calcium hydroxide Other: TheraCal LC Other: Er,Cr:YSGG laser + TheraCal LC Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Er,Cr:YSGG Laser Irradiation Combined With Resin Based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: a Randomized Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Active Comparator: Calcium hydroxide
Direct pulp capping with a self-hardening calcium hydroxide paste
Other: Calcium Hydroxide
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
Other Name: Dycal, Dentsply, Tulsa, OK, USA

Experimental: Er,Cr:YSGG laser + calcium hydroxide
Direct pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide
Other: Er,Cr:YSGG laser + calcium hydroxide
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
Other Name: Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA)

Experimental: TheraCal LC
Direct pulp capping with resin based tricalcium silicate material
Other: TheraCal LC
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
Other Name: TheraCal LC, Bisco, Schaumburg, Illinois, USA

Experimental: Er,Cr:YSGG laser + TheraCal LC
Direct pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material
Other: Er,Cr:YSGG laser + TheraCal LC
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




Primary Outcome Measures :
  1. Pulp vitality [ Time Frame: 3 months ]
    Pulp vitality is assessed with electric pulp tester as vital or non-vital

  2. Assessment of pain with questionnaire [ Time Frame: 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.


Secondary Outcome Measures :
  1. Radiographic success [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487329


Sponsors and Collaborators
Near East University, Turkey
Investigators
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Study Director: Hasan Guney Yılmaz, DDS,PhD Near East University

Publications of Results:
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Responsible Party: Esra Cengiz, DDS,PhD, Near East University, Turkey
ClinicalTrials.gov Identifier: NCT02487329     History of Changes
Other Study ID Numbers: 2015/30-197
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015

Keywords provided by Esra Cengiz, Near East University, Turkey:
Direct pulp capping
Er,Cr:YSGG laser
Tricalcium silicate

Additional relevant MeSH terms:
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Dental Pulp Exposure
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents