UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045692 |
|---|---|
| Receipt number | R000052149 |
| Scientific Title | Observation of the effect of bone filling material on healing of bone defect in apicoectomy. |
| Date of disclosure of the study information | 2021/10/19 |
| Last modified on | 2021/10/06 22:52:09 |
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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
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
y.kaki@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052149
