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
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
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
NCT ID
NCT02487329
First Posted
June 22, 2015
Last Updated
June 26, 2015
Sponsor
Near East University, Turkey
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
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The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping
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