UMIN-CTR Clinical Trial

Basic information
Public title	assessment of the periodontal tissue of erupted tooth by traction
Acronym	assessment of the periodontal tissue of erupted tooth by traction
Scientific Title	assessment of the periodontal tissue of erupted tooth by traction; opened technique versus closed technique
Scientific Title:Acronym	assessment of the periodontal tissue of erupted tooth by traction; opened technique versus closed technique
Region	Japan

Condition
Condition	patient with impacted tooth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to clarify which treatment strategy provide better outcome for periodontal tissue after eruption by tracing with opened and closed technique
Basic objectives2	Others
Basic objectives -Others	side effects
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the width of the keratinized gingiva 6 months after eruption
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	opened technique
Interventions/Control_2	closed technique
Interventions/Control_3
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. any age 2. any gender 3. inpatient/outpatient 4. no systematic disease 5. no informed consent
Key exclusion criteria	1. allergy 2. ionic allergy 3. pregnant 4. bone metabolism drug therapy 5. taking other clinical research 6. not appropriate to join the study 7. DM, kidney and hepatic disporders
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Department of Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Email	sohba@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Department of Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Homepage URL
Email	sohba@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki
Tel	095-819-7704
Email	sohba@nagasaki-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 02 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	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 01 Month 30 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	fifteen cases were recruited. 2 cases were done.

Management information
Registered date	2020 Year 01 Month 28 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044797