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

June 26, 2015 updated by: Esra Cengiz, Near East University, Turkey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulp vitality
Time Frame: 3 months
Pulp vitality is assessed with electric pulp tester as vital or non-vital
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Near East University, Turkey

Investigators

  • Study Director: Hasan Guney Yılmaz, DDS,PhD, Near East University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/30-197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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