臨床研究等提出・公開システム

Scientific Title	Evaluation of the efficacy of Cytrans Elashield on alveolar ridge preservation with open membrane technique
Public Title	Clinical study for alveolar ridge preservation using Cytrans Elashield

Completion date	Oct. 24, 2022
Result actual enrolment	10
Baseline Characteristics	Patients, who wanted to undergo dental implant treatment after extraction of the hopeless tooth from January in 2021 to March in 2022, were included in this study. All candidates were matched with the following criteria.
Participant flow	Done followed by the protocol.
Adverse events	None.
Outcome measures	There was no region and measured point which changed significantly in augmented alveolar bone height from T1 to T2. The alveolar bone height was decreased by 1.65 mm at palatal side of the maxillary anterior region, and by 1.38 mm at the center of the mandibular molar region. The height was decreased by less than 1 mm at the other regions.
Brief summary	The alveolar bone preservation showed few bone resorption after tooth extraction without infection by open-healing technique with P(LA/CL) membrane and CAG. The bone heigh changed less than 1 mm after surgery at most regions. The width was significantly decreased by 0.91mm. However, each of them was negligibly. In fact, implant placement was allowed without an additional bone augmentation. Moreover, it is not necessary to provide the tension-reducing incision and remove the membrane in this method.
Date of posting of results summaries	June. 01, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	None.
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs072200062

Contact for Scientific Queries	Name	Ohba Seigo
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
	Telephone	+81-95-819-7704
	E-mail	sohba@nagasaki-u.ac.jp
Contact for Public Queries	Name	Ohba Seigo
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture
	Telephone	+81-95-819-7704
	E-mail	sohba@nagasaki-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 09, 2020
Actual date of first enrollment		Feb. 03, 2021
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	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who have teeth which need to be extracted and want to have a prosthetic treatment with dental implants. 2. 20 plus and under 90 years old. 3. Patients who make written informed consent.
	Exclusion Criteria	1. Patients who have sever blood disease 2. Patients who have calcium metabolism disorder or suspected to be connective tissue diseases 3. Patients who are difficult to visit for follow-up 4. Patients who are difficult to comply the contens of this study 5. Smokers 6. Patients who need the legal representative 7. Patients who are judged to be inappropriate to participate this study
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dental caries and/or periodontitis
Intervention(s)		Alveolar ridge preservation using Cytrans Elashield in limited number of subjects
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Amount of bone formation
Secondary Outcome(s)		Safety and amount of keratinized gingival tissue

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Clinical Research Review Board in Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken, Nagasaki
Telephone	+81-95-819-7229
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 30, 2020

Secondary ID(s)	なし
Issuing Authority	none

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history