UMIN-CTR Clinical Trial

Basic information
Public title	Observation of the effect of bone filling material on healing of bone defect in apicoectomy.
Acronym	Observation of the effect of bone filling material on healing of bone defect in apicoectomy.
Scientific Title	Observation of the effect of bone filling material on healing of bone defect in apicoectomy.
Scientific Title:Acronym	Observation of the effect of bone filling material on healing of bone defect in apicoectomy.
Region	Japan

Condition
Condition	radicular cyst.
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observe the effect of alveolar bone recovery using a bone graft material with high bone regeneration ability for the purpose of recovery of the alveolar bone defect that cannot be healed spontaneously lost because of apical periodontitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the condition of the bone defect one year after the surgery by x-ray.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The GBR method is performed in which the bone defect after apicoectomy is filled with a refit dental and the outside is covered with an elashield membrane.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Disease name Apical periodontitis Periapical cyst (WZ) Bone defect with a maximum diameter of 5 mm or more on dental X-ray (2) Patients who are scheduled to do apicoectomy at the Department of Endodontics of our university
Key exclusion criteria	(1) Patients with or have a history of malignant tumor (2) Patients with or have a history of abnormal gingival overgrowth (3) Oral diagnosis reveals malignant tumors, precancerous lesions or suspected findings (4) Patients under 20 years old or over 70 years old (at the time of registration) (5) Other safety for patients suffering from serious infections and the dentist deems inappropriate apicoectomy Consider conducting interviews and inspections on the following items from the perspective of countermeasures. (A) Hepatitis B virus (HBV) (B) Hepatitis C virus (HCV) (C) Human immunodeficiency virus (HIV) (d) Human T-cell leukemia virus type 1 (HTLV-1)
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Masahito Middle name Last name Saito
Organization	Tohoku university
Division name	Operative dentistry
Zip code	9808575
Address	4-1, Seiryo-cho, Aoba-ku, Sendai-shi
TEL	0227178340
Email	masahiro.saito.c5@tohoku.ac.jp

Public contact
Name of contact person	1st name yusuke Middle name Last name kakiuchi
Organization	Tohoku university
Division name	Operative dentistry
Zip code	9808575
Address	4-1, Seiryo-cho, Aoba-ku, Sendai-shi
TEL	0227178340
Homepage URL
Email	y.kaki@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku university
Address	4-1, Seiryo-cho, Aoba-ku, Sendai-shi
Tel	0227178340
Email	y.kaki@tohoku.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	2021 Year 10 Month 19 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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 19 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 06 Day
Last modified on	2021 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052149