UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055311 |
|---|---|
| Receipt number | R000063210 |
| Scientific Title | OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2024/08/22 18:46:31 |
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Basic information
Public title
OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY
Acronym
OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY
Scientific Title
OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY
Scientific Title:Acronym
OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY
Region
| Asia(except Japan) |
Condition
Condition
Partial edentulism of the mandible with no history of smoking & systemic condition
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to evaluate the initial efficacy assessment of novel dental implant ("Merah Putih" dental implant) from osseointegration process and its safety in human alveolar bone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The osseointegration of dental implant from clinical and dental radiography parameter (bone density and bone to implant contact.
Key secondary outcomes
The nature of osseointegration takes time to observe so the study will be conducted for 12 weeks after dental implant insertion in human alveolar bone.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects will have dental implant procedure with standard osteotomy technique for dental implant using selected drilling sequences in posterior mandible. Following osteotomy procedure, the novel dental implant in this study with the size of 4 mm in diameter and 10 mm in length is inserted into the site (0,5 mm to 1 mm submerged in alveolar bone) with selected drilling sequences. The neck of dental implant is covered with cover screw that comes along with the dental implant. Suturing of the dental implant is conducted so the evaluation of its osseointegration process inside the alveolar bone can be done for at least 3 months following the dental implant procedure. Subjects will be instructed to have control visits in 3, 7, 14 days and 4,8,12 weeks for clinical and radiography assessment. The result of 12 weeks observation will be determined from clinical and radiography parameters (bone density & bone to implant contact measurement).
Interventions/Control_2
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
| 54 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male/Female subjects who give consent for the intervention.
2. Edentulism condition of posterior mandible more than 4 months after tooth extraction.
3. Alveolar bone volume is adequate for dental implant with the size of 4 mm in diameter and 10 mm in length.
4. Good oral hygiene control (O'leary plaque index less than 20%).
5. The interocclusal distance of the edentulous is adequate for dental crown (minimum of 7 mm).
Key exclusion criteria
1. Subjects with smoking habit.
2. Subjects with pregnancy and breastfeeding condition.
3. Subjects with systemic diseases (diabetes, osteoporosis, hypertension, arthritis, hypothyroidism, parathyroidism, and blood disorders).
4. Subjects with routine antibiotics, anti-inflammation, biphosphonates, hormone replacement therapy, and corticosteroid drugs consumption 6 months prior to dental implant procedure.
5. Subjects with history of alveolar bone augmentation at implant site 6 months prior to dental implant procedure.
6. Subjects with history of tooth extraction 3 months prior to dental implant procedure.
7. Subjects with the needs of bone/soft tissue grafting at dental implant insertion.
8. Subjects with physical disorders that are able to interfere the oral hygiene maintenance.
9. Subjects with history of head & neck radiotherapy.
10. Subjects with bad oral habit (bruxism & clenching).
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Ira |
| Middle name | |
| Last name | Komara |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Department of Periodontics
Zip code
40132
Address
Jalan Sekeloa Selatan No.1, Lebakgede, Kecamatan Coblong, Kota Bandung
TEL
+628122026778
ira.komara@fkg.unpad.ac.id
Public contact
Name of contact person
| 1st name | Syifa |
| Middle name | |
| Last name | Nurrahman |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Department of Periodontics
Zip code
40132
Address
Jalan Sekeloa Selatan No.1, Lebakgede, Kecamatan Coblong, Kota Bandung
TEL
+6282373327646
Homepage URL
drg.syifanurrahman@gmail.com
Sponsor or person
Institute
Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran
Institute
Department
Personal name
-
Funding Source
Organization
Indonesia Endowment Fund for Education (Lembaga Pengelola Dana Pendidikan)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Indonesian
Other related organizations
Co-sponsor
-
Name of secondary funder(s)
-
IRB Contact (For public release)
Organization
Research Ethic Committee Universitas Padjadjaran
Address
Jl. Prof. Eyckman No. 38 Bandung
Tel
022-2038697
kepk.fk.unpad@gmail.com
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
Dental & Oral Hospital Universitas Padjadjaran
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 22 | 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
6
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 21 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 21 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063210
