UMIN-CTR Clinical Trial

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
Email	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
Email	natsuaya1023@gmail.com

Sponsor
Institute	Omura Municipal Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051850