UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of hydroxyapatite agarose gel on the bone healing in the bony defect around the implant after immediate implant placement -retrospective study-
Title of the study (Brief title)	Effects of hydroxyapatite agarose gel on the bone healing after implant placement
Region	Japan

Condition
Condition	missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This retrospective study evaluated the influence of hydroxyapatite agarose gel on changes in marginal bone level after immediate implant placement, in maxillary and mandibular posterior fresh sockets where bony defect height was > 5mm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Radiographic measurements of marginal bone loss were conducted via panoramic xray. The vertical distance between a reference point (implant-abutment interface) and the corresponding bone-to-implant contact point was measured (radiographic bone loss). The bone loss in millimeters detected radiographically was divided by the magnification factor to calculate actual bone loss. Bone level changes were calculated both medially and distally, based on the baseline and 3-year follow-up measurements. The deepest measurements of each implant at each time-point were calculated and recorded as proximal bone defect.
Key secondary outcomes	Peri-implant probing depth (PD) was determined at four sides of each implant, buccally, palatally, mesially, and distally. The deepest PD at the 3- year follow-up was recorded.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hydroxyapatite agarose gel is a synthetic hybrid of organic and inorganic materials, and contains hemostatic material. Bone-like apatite could be formed on or in organic polymer hydrogel matrices via the process using alternate soaking process. Hydroxyapatite agarose gel was filled In the bony defect around the implant . Bone substitute was filled in the bony defect after immediate implant placement.
Interventions/Control_2	Commercially available bone substitute was filled in the bony defect.
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	good systemic and oral health, (2) radiographically >5-mm bone height defect between a reference point (implant-abutment interface) and the corresponding bone-to-implant contact point, (3) >2-mm gap between the implant and socket wall on baseline.
Key exclusion criteria	The exclusive criteria were use of potentially interfering medication (e.g., steroid therapy or bisphosphonates), alcohol or drug abuse noted in the patient's records of medical history, heavy smoking(more than 10 cigarettes/day), and uncontrolled diabetes.
Target sample size	50

Research contact person
Name of lead principal investigator	masashi tabata
Organization	Miyakonojo National Hospital
Division name	Oral and Maxillofacial Surgery
Address	5033-1 Iwayoshi-cho Miyakonojo Miyazaki
TEL	0986-23-4111
Email	tabatam@mac.com

Public contact
Name of contact person	masashi tabata
Organization	Miyakonojo National Hospital
Division name	Oral and Maxillofacial Surgery
Address	5033-1 Iwayoshi-cho Miyakonojo Miyazaki
TEL	0986-23-4111
Homepage URL
Email	tabatam@mac.com

Sponsor
Institute	Miyakonojo National Hospital Department of oral and Maxillofacial Surgery
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	都城医療センター（宮崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 20 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 27 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030633