UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045413 |
|---|---|
| Receipt number | R000051850 |
| Scientific Title | Comparative analysis of two flap designs for the extraction of impacted mandibular horizontal third molars: a multicenter randomized control trial |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2021/09/07 21:00:27 |
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Basic information
Public title
Comparative analysis of two flap designs for the extraction of impacted mandibular horizontal third molars: a multicenter randomized control trial
Acronym
Comparative analysis of two flap designs for the extraction of impacted mandibular horizontal third molars: a multicenter randomized control trial
Scientific Title
Comparative analysis of two flap designs for the extraction of impacted mandibular horizontal third molars: a multicenter randomized control trial
Scientific Title:Acronym
Comparative analysis of two flap designs for the extraction of impacted mandibular horizontal third molars: a multicenter randomized control trial
Region
| Japan |
Condition
Condition
impacted mandibular horizontal third molars
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This multicenter randomized clinical trial (RCT) was conducted to examine the early postoperative complications in mandibular horizontal third molars and to compare the effects of the two flap designs. Achieving this goal will most likely suggest the usefulness of mEF with resultant reduced postoperative complications for patients and enhanced quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The primary endpoint of the study was the difference in the postoperative complications (postoperative pain, hemorrhage, paralysis of the inferior dental nerve, dry socket, and infection) between mEF and TF.
Key secondary outcomes
The secondary endpoint of the study was the difference in the operation time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
modified envelope flap
Interventions/Control_2
Triangular flap
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were patients: (1) 20 years or older with impacted mandibular horizontal third molars under local anesthesia in outpatients; (2) with an indication for the extraction of impacted mandibular horizontal third molars; and (3) signed informed consent form for participation and permission to use the obtained data for research purposes.
Key exclusion criteria
(1) deficiency of the mandibular second molars; (2) taking an anticancer drug, an immunosuppressive drug, or an antithrombotic drug; and (3) with a systemic disease that prevents surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki University
Division name
Department of Clinical Oral Oncology
Zip code
856-8561
Address
1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Omura Municipal Hospital
Division name
Department of Dentistry and Oral Surgery
Zip code
856-8561
Address
133-22 Kogashima, Omura 856-8561, Japan
TEL
0957-52-2161
Homepage URL
natsuaya1023@gmail.com
Sponsor or person
Institute
Omura Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Omura Municipal Hospital
Address
133-22 Kogashima, Omura 856-8561, Japan
Tel
0957-52-2161
naruse12@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
31
Org. issuing International ID_1
Omura Municipal Hospital
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 | 09 | Month | 07 | 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
188
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 08 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 08 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051850
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
