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

NCT ID: NCT02487329

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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

Conditions

Dental Pulp Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calcium hydroxide

Direct pulp capping with a self-hardening calcium hydroxide paste

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Er,Cr:YSGG laser + calcium hydroxide

Intervention Type: OTHER

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

Direct pulp capping with resin based tricalcium silicate material

Group Type: EXPERIMENTAL

TheraCal LC

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Er,Cr:YSGG laser + TheraCal LC

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Dycal, Dentsply, Tulsa, OK, USA; Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA); TheraCal LC, Bisco, Schaumburg, Illinois, USA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Near East University, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Esra Cengiz

DDS,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Guney Yılmaz, DDS,PhD

Role: STUDY_DIRECTOR

Near East University

References

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.

Reference Type: RESULT

PMID: 17571933 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24756324 (View on PubMed)

Other Identifiers

2015/30-197

Identifier Type: -

Identifier Source: org_study_id