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

Primary Purpose

Dental Pulp Exposure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calcium Hydroxide
Er,Cr:YSGG laser + calcium hydroxide
TheraCal LC
Er,Cr:YSGG laser + TheraCal LC
Sponsored by
Near East University, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Exposure focused on measuring Direct pulp capping, Er,Cr:YSGG laser, Tricalcium silicate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Calcium hydroxide

    Er,Cr:YSGG laser + calcium hydroxide

    TheraCal LC

    Er,Cr:YSGG laser + TheraCal LC

    Arm Description

    Direct pulp capping with a self-hardening calcium hydroxide paste

    Direct pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide

    Direct pulp capping with resin based tricalcium silicate material

    Direct pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material

    Outcomes

    Primary Outcome Measures

    Pulp vitality
    Pulp vitality is assessed with electric pulp tester as vital or non-vital
    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    June 22, 2015
    Last Updated
    June 26, 2015
    Sponsor
    Near East University, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487329
    Brief Title
    The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Near East University, Turkey

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pulp Exposure
    Keywords
    Direct pulp capping, Er,Cr:YSGG laser, Tricalcium silicate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Calcium hydroxide
    Arm Type
    Active Comparator
    Arm Description
    Direct pulp capping with a self-hardening calcium hydroxide paste
    Arm Title
    Er,Cr:YSGG laser + calcium hydroxide
    Arm Type
    Experimental
    Arm Description
    Direct pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide
    Arm Title
    TheraCal LC
    Arm Type
    Experimental
    Arm Description
    Direct pulp capping with resin based tricalcium silicate material
    Arm Title
    Er,Cr:YSGG laser + TheraCal LC
    Arm Type
    Experimental
    Arm Description
    Direct pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material
    Intervention Type
    Other
    Intervention Name(s)
    Calcium Hydroxide
    Other Intervention Name(s)
    Dycal, Dentsply, Tulsa, OK, USA
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Er,Cr:YSGG laser + calcium hydroxide
    Other Intervention Name(s)
    Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA)
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    TheraCal LC
    Other Intervention Name(s)
    TheraCal LC, Bisco, Schaumburg, Illinois, USA
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Er,Cr:YSGG laser + TheraCal LC
    Intervention Description
    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 Measure Information:
    Title
    Pulp vitality
    Description
    Pulp vitality is assessed with electric pulp tester as vital or non-vital
    Time Frame
    3 months
    Title
    Assessment of pain with questionnaire
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Radiographic success
    Description
    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
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hasan Guney Yılmaz, DDS,PhD
    Organizational Affiliation
    Near East University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17571933
    Citation
    Olivi G, Genovese MD, Maturo P, Docimo R. Pulp capping: advantages of using laser technology. Eur J Paediatr Dent. 2007 Jun;8(2):89-95.
    Results Reference
    result
    PubMed Identifier
    24756324
    Citation
    Yazdanfar I, Gutknecht N, Franzen R. Effects of diode laser on direct pulp capping treatment : a pilot study. Lasers Med Sci. 2015 May;30(4):1237-43. doi: 10.1007/s10103-014-1574-8. Epub 2014 Apr 23.
    Results Reference
    result

    Learn more about this trial

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

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