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

Dental Pulp Exposure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487329
• Other study ID #: 2015/30-197
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 26, 2015
• Start date: January 2015

Study information

• Verified date: June 2015
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Exposure

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulp vitality	Pulp vitality is assessed with electric pulp tester as vital or non-vital	3 months	No
Primary	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.	3 months	No
Secondary	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	3 months	No