臨床研究等提出・公開システム

Date of registration	Mar. 05, 2019
Last modified on	April. 04, 2024
Trial ID	jRCTs012180009

Scientific Title	The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial (PT-Study)
Public Title	The effectiveness of porcelain teeth in complete dentures: non-blind randomized controlled trial (PT-Study)

Contact for Scientific Queries	Name	takayama yoshiyuki
	Affiliation	Hokkaido University Hospital
	Address	kita 15 nishi 5, kita-ku, sapporo, hokkaido
	Telephone	+81-11-706-4270
	E-mail	takayama@den.hokudai.ac.jp
Contact for Public Queries	Name	nogawa toshifumi
	Affiliation	Hokkaido university hospital
	Address	kita 13 nishi 7, kita-ku, sapporo, hokkaido
	Telephone	+81-11-706-4270
	E-mail	t.nogawa@den.hokudai.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment
Target sample size		66
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with complete dentures
	Exclusion Criteria	severe alveolar rigde resorption, Maxillofacial Prothetics, severe xerostomia
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Edentulous Patients
Intervention(s)		Type of artificial teeth
Primary Outcome(s)		Oral health related Quality of Life (OHIP-EDENT) (3months after insertion of complete dentures)
Secondary Outcome(s)		satisfaction masticatory performance occlusal force

Source of Monetary Support / Secondary Sponsor	Shofu Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hokkaido University Clinical Research Review Board
Address	Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-706-7934
E-Mail	recjimu@huhp.hokudai.ac.jp
Approval Status	Approval

Plan to share IPD	No

Secondary ID(s)	UMIN000031164
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	April. 04, 2024	(this page)	Changes
6	Jan. 16, 2024	Detail	Changes
5	May. 16, 2022	Detail	Changes
4	Feb. 24, 2022	Detail	Changes
3	Mar. 19, 2021	Detail	Changes
2	June. 17, 2019	Detail	Changes
1	Mar. 05, 2019	Detail

List of change history