UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053498 |
|---|---|
| Receipt number | R000058952 |
| Scientific Title | The Impact of Implant Depth in Oral Implant Treatment: A Clinical study |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/04/20 11:00:08 |
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Basic information
Public title
The Impact of Implant Depth in Oral Implant Treatment: A Clinical study
Acronym
The Impact of Implant Depth in Oral Implant Treatment: A Clinical study
Scientific Title
The Impact of Implant Depth in Oral Implant Treatment: A Clinical study
Scientific Title:Acronym
The Impact of Implant Depth in Oral Implant Treatment
Region
| Japan |
Condition
Condition
Missing tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the effect of implant placement depth on marginal bone loss in patients with thin gingiva, which is characteristic of Asians.
Basic objectives2
Others
Basic objectives -Others
Assessing changes in implant marginal bone height.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implant marginal bone height(Amount of marginal bone loss)
Key secondary outcomes
Age, gender, tooth type, maxillary and maxillary,medical history, type of opposite tooth, smoking, boneDensity, insertion torque value, tooth type proximal and distal to the implant placement site, PI, BOP, Pd, gingival thickness, type of implant, type of abutment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implants are inserted crestally and abutments are fixed.
Interventions/Control_2
Implants are inserted 1mm subcrestally and abutments are fixed.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with partial dentition defects who will undergo implant treatment for the defects.
Written informed consent can be obtained from the patient.
Gingival thickness less than or equal to 2 mm at the site of implant placement on preoperative CT scan.
Good periodontal status, stable (BOP<15%, PI<20%).
No bone grafting.
Bicuspids and molars.
Late implant placement.
Have a sufficient amount of bone to place implants.
Fixed restorations or natural teeth as a counterpart.
Prosthetic space of at least 5 mm.
Key exclusion criteria
History of long-term use of drugs that may interfere with bone metabolism.
History of neoplastic disease treated with radiation or chemotherapy.
History of renal failure.
Osteoporosis.
History of uncontrolled endocrine disease.
Alcoholism or drug abuse.
Smoking.
Pregnant or lactating.
Gingival thickness less than 1mm.
History of implant failure.
Patients with dementia or other conditions that make it difficult to confirm the patient's will.
Patients who have undergone implant placement surgery only and are scheduled to be transferred to a hospital afterward.
Patients with low compliance whom the investigator judged to be inappropriate to participate in this study.
Abutment cannot be placed at the time of surgery
Implants that require osteogenesis during implant surgery.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Arai |
Organization
Niigata University Medical & Dental Hospital
Division name
Oral Implant and Temporomandibular Joint Clinic
Zip code
951-8520
Address
754 Asahimachi-1, Chuo-ku, Niigata-city, Niigata, Japan
TEL
0252272975
takashima@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Takashima |
Organization
Niigata University Medical & Dental Hospital
Division name
Oral Implant and Temporomandibular Joint Clinic
Zip code
951-8520
Address
754 Asahimachi-1, Chuo-ku, Niigata-city, Niigata, Japan
TEL
0252272975
Homepage URL
takashima@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Medical & Dental Hospital
Address
754 Asahimachi-1, Chuo-ku, Niigata-city, Niigata, Japan
Tel
0252272975
takashima@dent.niigata-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-0117
Org. issuing International ID_1
Niigata University Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058952
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