UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Induction of dentin bridge formation after direct pulp capping with carbon dioxide laser irradiation
Title of the study (Brief title)	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	Masaya Suzuki
Organization	The Nippon Dental University School of Life Dentistry at Niigata
Division name	Dept. of Operative Dentistry
Address	1-8 Hamaura-cho, Chuo-ku Niigata, 951-8580, Japan
TEL	025-267-1500
Email	collagen@ngt.ndu.ac.jp

Public contact
Name of contact person	Masaya Suzuki
Organization	The Nippon Dental University School of Life Dentistry at Niigata
Division name	Dept. of Operative Dentistry
Address	1-8 Hamaura-cho, Chuo-ku Niigata, 951-8580, Japan
TEL	025-267-1500
Homepage URL
Email	collagen@ngt.ndu.ac.jp

Sponsor
Institute	Dept. of Operative Dentistry, The Nippon Dental University School of Life Dentistry at Niigata
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009883