UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061025 |
|---|---|
| Receipt number | R000069837 |
| Scientific Title | A Study on the Effects Of Collagen-Based Absorbable Topical Hemostatic Agent (TERUPLUG )on Postoperative Bleeding and Alveolar Socket Wound Healing Following Extraction of Impacted Mandibular Third Molars |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/23 19:56:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Effects of TERUPLUG on Postoperative Bleeding and Alveolar Socket Wound Healing Following Extraction of Impacted Mandibular Third Molars
Acronym
Efficacy of Terplug in Healing Extraction Sockets
Scientific Title
A Study on the Effects Of Collagen-Based Absorbable Topical Hemostatic Agent (TERUPLUG )on Postoperative Bleeding and Alveolar Socket Wound Healing Following Extraction of Impacted Mandibular Third Molars
Scientific Title:Acronym
THE Study
Region
| Japan |
Condition
Condition
Completely impacted mandibular third molar
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Teruplug for Reducing Postoperative Complications and Promoting Wound Healing in Mandibular Impacted Wisdom Tooth Extraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of abnormal pain after tooth extraction
Presence of infection after tooth extraction
Intensity of postoperative pain
Presence of bleeding after tooth extraction
Key secondary outcomes
Modified Healing Index (MHI) and pain score
Attachment loss in the distal central region of the second molar
Changes in soft tissue contour in the horizontal and vertical directions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
With Terplug insertion into the extraction socket
Single intervention during extraction
Interventions/Control_2
Without Terplug insertion into the extraction socket
Single intervention during extraction
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing extraction of completely impacted mandibular third molars
Postoperative use of antibiotics and analgesics is not restricted when used appropriately
Key exclusion criteria
Patients with diabetes or osteoporosis
Patients taking antithrombotic drugs
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | IWABUCHI |
Organization
International University of Health and Welfare Hospital
Division name
Dentistry & Oral Surgery
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara, Tochigi, Japan
TEL
+81-0287-39-3060
hiwabuchi@ihwg.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | IWABUCHI |
Organization
International University of Health and Welfare Hospital
Division name
Dentistry & Oral Surgery
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara, Tochigi, Japan
TEL
+81-0287-39-3060
Homepage URL
hiwabuchi@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
International University of Health and Welfare Tochigi District Ethics Review Committee Secretariat
Address
537-3 Iguchi, Nasushiobara, Tochigi, Japan
Tel
+81-0287-39-3060
s-rinri@ihwg.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069837
