Dental Pulp ExposureNCT02487329
The Effect of Laser Combined With Pulp-capping Agents on Direct Pulp Capping
A study testing Calcium Hydroxide, Er,Cr:YSGG laser + calcium hydroxide and TheraCal LC in people with Dental Pulp Exposure, run by Near East University, Turkey.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Pulp Exposure
- What is being tested?
- Calcium Hydroxide, Er,Cr:YSGG laser + calcium hydroxide and TheraCal LC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Being tested
- Calcium Hydroxide, Er,Cr:YSGG laser + calcium hydroxide, TheraCal LC, Er,Cr:YSGG laser + TheraCal LC
- Keywords
- Direct pulp capping, Er,Cr:YSGG laser, Tricalcium silicate
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium HydroxideOther
Also called Dycal, Dentsply, Tulsa, OK, USA
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 hydroxideOther
Also called Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA)
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 LCOther
Also called TheraCal LC, Bisco, Schaumburg, Illinois, USA
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 LCOther
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
| Study group | Role | What they receive |
|---|---|---|
| Calcium hydroxide | Active comparator | Direct pulp capping with a self-hardening calcium hydroxide paste Receives: Other: Calcium Hydroxide |
| Er,Cr:YSGG laser + calcium hydroxide | Experimental | Direct pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide Receives: Other: Er,Cr:YSGG laser + calcium hydroxide |
| TheraCal LC | Experimental | Direct pulp capping with resin based tricalcium silicate material Receives: Other: TheraCal LC |
| Er,Cr:YSGG laser + TheraCal LC | Experimental | Direct pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material Receives: Other: Er,Cr:YSGG laser + TheraCal LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp vitality
Pulp vitality is assessed with electric pulp tester as vital or non-vital
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Cengiz, Near East University, Turkey
- Investigators
- Hasan Guney Yılmaz, DDS,PhD, Study director, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487329
- Sponsor's protocol ID
- 2015/30-197
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17571933Yazdanfar 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.
PubMed 24756324
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02487329
- Acronym / sponsor ID
- 2015/30-197
- Conditions
- Dental Pulp Exposure
- Keywords
- Direct pulp capping, Er,Cr:YSGG laser, Tricalcium silicate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calcium hydroxide | Active comparator | Other: Calcium HydroxideDirect pulp capping with a self-hardening calcium hydroxide paste |
| Er,Cr:YSGG laser + calcium hydroxide | Experimental | Other: Er,Cr:YSGG laser + calcium hydroxideDirect pulp capping using Er,Cr:YSGG laser combined with calcium hydroxide |
| TheraCal LC | Experimental | Other: TheraCal LCDirect pulp capping with resin based tricalcium silicate material |
| Er,Cr:YSGG laser + TheraCal LC | Experimental | Other: Er,Cr:YSGG laser + TheraCal LCDirect pulp capping using Er,Cr:YSGG laser combined with resin based tricalcium silicate material |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium HydroxideAlso: Dycal, Dentsply, Tulsa, OK, USAExposed 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 | Calcium hydroxide |
| Er,Cr:YSGG laser + calcium hydroxideAlso: Er,Cr:YSGG laser (Waterlase MD, Biolase, Irvine, CA, USA)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 | Er,Cr:YSGG laser + calcium hydroxide |
| TheraCal LCAlso: TheraCal LC, Bisco, Schaumburg, Illinois, USATheraCal 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 | TheraCal LC |
| Er,Cr:YSGG laser + TheraCal LCAfter 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 | Other | Er,Cr:YSGG laser + TheraCal LC |
Primary outcome
Pulp vitality
Time frame: 3 months
Pulp vitality is assessed with electric pulp tester as vital or non-vital
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.
1 secondary outcome
Radiographic success
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Results publication: PubMed 17571933Olivi G, Genovese MD, Maturo P, Docimo R. Pulp capping: advantages of using laser technology. Eur J Paediatr Dent. 2007 Jun;8(2):89-95.
- Results publication: PubMed 24756324Yazdanfar 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.
Related trials for Dental Pulp Exposure
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
Active, not recruiting
Pulpotomy in Hypominerlized Permanent Molars.
Molar Hypomineralization
Active, not recruiting
Direct Pulp Capping Compared to Partial Pulpotomy in Carious Pulp Exposures
Deep Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Guney Yılmaz, DDS,PhD study director
Near East University
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide, Er,Cr:YSGG laser + calcium hydroxide and TheraCal LC in people with Dental Pulp Exposure, run by Near East University, Turkey.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp vitality (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487329, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.