臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 12, 2024
Last modified on	July. 18, 2025
Trial ID	jRCTs032240332

Scientific Title	Assessment of the efficacy of biodegradable materials, poly(L-lactic Acid/ipsilon-Caprolactone) membrane and poly(L-lactic-co-glycolic acid) pin for guided bone regeneration ( Assessment of the efficacy of biodegradable materials, P(LA/CL) membrane and PLGA pin for GBR)
Public Title	Study of bone augmentation with biodegradable materials (Study of bone augmentation with biodegradable materials)

Contact for Scientific Queries	Name	Seigo Ohba
	Affiliation	SHOWA Medical University Dental Hospital
	Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515 Japan
	Telephone	+81-3-3787-1151
	E-mail	sohba@dent.showa-u.ac.jp
Contact for Public Queries	Name	Seigo Ohba
	Affiliation	SHOWA Medical University Dental Hospital
	Address	2-1-1 Kitasenzoku, Ota-ku, Tokyo 145-8515 Japan
	Telephone	+81-3-3787-1151
	E-mail	sohba@dent.showa-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 12, 2024
Actual date of first enrollment
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who undergo dental implant treatment and have insufficient alveolar bone volume at the implant placement site and therefore require bone augmentation by GBR prior to implant placement. 2. Age: 20 and older than 20, and younger than 90. 3. Patients who have sufficient explanation about this study and agree to participant in this study by their own decision.
	Exclusion Criteria	1. Patients with severe hematological diseases 2. Patients with abnormalities in kidneys, digestive organs, or other calcium-metabolizing organs, or suspected collagen disease 3. Patients who are not expected to visit the hospital at the decided dates. 4. Patients who are not followed the protocol of this study. 5. Patients who smoke 6. Pregnant or lactating patients 7. Patients who can not show their own decision by themselves. 8. Patients who have illnesses which are listed in data sheet. 9. Patients who are not considered to be suitable to join this study by the researchers.
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Severe alveolar bone atrophy
Intervention(s)		use biodegradable pin
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		efficacy: augmented bone volume according to CBCT images. bone volume was evaluated before, right after, 150 plus/minus 28 days after GBR, and after dental implant placement by CT data.
Secondary Outcome(s)		1. safety; adverse event during the study 2, efficacy: Ncm values of implant placement. 3. efficacy: ISQ value after dental implant placement. 4. efficacy: Histological evaluation with bone biopsy.

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	GC Corporation
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	SHOWA Medical University Clinical Research Review Board
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Telephone	+81-3-3784-8129
E-Mail	ura-ec@ofc.showa-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 06, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 18, 2025	(this page)	Changes
1	Sept. 12, 2024	Detail

List of change history