Clinical trial NCT02487329: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Exposure
Keywords: Direct pulp capping
Er,Cr:YSGG laser
Tricalcium silicate
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pulp vitality
timeFrame: 3 months
measure: Assessment of pain with questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Radiographic success
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Near East University
name: Hasan Guney Yılmaz, DDS,PhD
role: STUDY_DIRECTOR
References:
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.
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.