UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027172 |
|---|---|
| Receipt number | 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 22:21:51 |
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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
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
tabatam@mac.com
Sponsor or person
Institute
Miyakonojo National Hospital
Department of oral and Maxillofacial Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030633
