The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping
Efficacy of Er,Cr:YSGG Laser Irradiation Combined With Resin Based Tricalcium Silicate and Calcium Hydroxide on Direct Pulp Capping: a Randomized Clinical Trial
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedJuly 1, 2015
June 1, 2015
5 months
June 22, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pulp vitality
Pulp vitality is assessed with electric pulp tester as vital or non-vital
3 months
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
Secondary Outcomes (1)
Radiographic success
3 months
Study Arms (4)
Calcium hydroxide
ACTIVE COMPARATORDirect pulp capping with a self-hardening calcium hydroxide paste
Er,Cr:YSGG laser + calcium hydroxide
EXPERIMENTALDirect pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide
TheraCal LC
EXPERIMENTALDirect pulp capping with resin based tricalcium silicate material
Er,Cr:YSGG laser + TheraCal LC
EXPERIMENTALDirect pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material
Interventions
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
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 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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 17571933RESULTYazdanfar 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.
PMID: 24756324RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hasan Guney Yılmaz, DDS,PhD
Near East University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS,PhD
Study Record Dates
First Submitted
June 22, 2015
First Posted
July 1, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Last Updated
July 1, 2015
Record last verified: 2015-06