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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027172
Receipt No. R000030633
Scientific Title Effects of hydroxyapatite agarose gel on the bone healing in the bony defect around the implant after immediate implant placement -retrospective study-
Date of disclosure of the study information 2017/05/08
Last modified on 2017/04/27

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Basic information
Public title Effects of hydroxyapatite agarose gel on the bone healing in the bony defect around the implant after immediate implant placement -retrospective study-
Acronym Effects of hydroxyapatite agarose gel on the bone healing after implant placement
Scientific Title Effects of hydroxyapatite agarose gel on the bone healing in the bony defect around the implant after immediate implant placement -retrospective study-
Scientific Title:Acronym 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
1st name
Middle name
Last name masashi tabata
Organization Miyakonojo National Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 5033-1 Iwayoshi-cho Miyakonojo Miyazaki
TEL 0986-23-4111
Email tabatam@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name masashi tabata
Organization Miyakonojo National Hospital
Division name Oral and Maxillofacial Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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