UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008424 |
|---|---|
| Receipt number | R000009883 |
| Scientific Title | Induction of dentin bridge formation after direct pulp capping with carbon dioxide laser irradiation |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2017/07/17 11:03:06 |
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Basic information
Public title
Induction of dentin bridge formation after direct pulp capping with carbon dioxide laser irradiation
Acronym
Direct pulp capping with carbon dioxide laser irradiation
Scientific Title
Induction of dentin bridge formation after direct pulp capping with carbon dioxide laser irradiation
Scientific Title:Acronym
Direct pulp capping with carbon dioxide laser irradiation
Region
| Japan |
Condition
Condition
Dental Caries
Fracture of the Tooth
(Direct Pulp Capping Treatment)
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of direct pulp capping treatment using super-pulsed carbon dioxide laser pre-irradiation on the wound healing process of exposed human pulp.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation Period: 3, 6, 12 months postoperatively
Evaluation Criteria: Pulp Tissue Disorganization, Inflammatory Cell Infiltration, Reparative Dentin (Dentin Bridge) Formation, Bacterial Penetration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The exposed pulp was irradiated with the carbon dioxide laser using the below-mentioned conditions. An Opelaser PRO was used in the carbon dioxide laser irradiation. The irradiation conditions were: a power output of 0.5 W, super-pulsed mode 1 (pulse duration of 200 microsecond, intervals of 5800 microsecond, 0.003 J/pulse), a total irradiation time of 15 seconds, repeat mode (10 msec irradiation and 10 msec interval, that means a total beam exposure time of 7.5 seconds), defocused beam diameter of 0.74 mm, energy density of 0.698 J/cm2/pulse, total applied energy of 3.75 J and activated air-cooling system.
Interventions/Control_2
The exposed pulp was irradiated with the carbon dioxide laser using the below-mentioned conditions. An Opelaser PRO was used in the carbon dioxide laser irradiation. The irradiation conditions were: a power output of 0.5 W, super-pulsed mode 2 (pulse duration of 50 microsecond, intervals of 1450 microsecond, 0.00075 J/pulse), a total irradiation time of 15 seconds, repeat mode (10 msec irradiation and 10 msec interval, that means a total beam exposure time of 7.5 seconds), defocused beam diameter of 0.74 mm, energy density of 0.1744 J/cm2/pulse, total applied energy of 3.75 J.
Interventions/Control_3
The exposed pulp was capped with the commercially available calcium hydroxide (Dycal).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Third Molars (Vital tooth)
(Tooth extraction is scheduled)
Key exclusion criteria
Pulpitis
Non-vital Tooth
Retention Tooth
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Suzuki |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Dept. of Operative Dentistry
Zip code
Address
1-8 Hamaura-cho, Chuo-ku Niigata, 951-8580, Japan
TEL
025-267-1500
collagen@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Suzuki |
Organization
The Nippon Dental University School of Life Dentistry at Niigata
Division name
Dept. of Operative Dentistry
Zip code
Address
1-8 Hamaura-cho, Chuo-ku Niigata, 951-8580, Japan
TEL
025-267-1500
Homepage URL
collagen@ngt.ndu.ac.jp
Sponsor or person
Institute
Dept. of Operative Dentistry, The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本歯科大学新潟病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009883
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| Registered date | File name |
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| Registered date | File name |
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