UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059625 |
|---|---|
| Receipt number | R000068203 |
| Scientific Title | A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/03 19:13:51 |
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Basic information
Public title
A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability
Acronym
A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability
Scientific Title
A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability
Scientific Title:Acronym
A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability
Region
| Asia(except Japan) |
Condition
Condition
Partial edentulism of the mandible with no history of smoking and 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 continuity efficacy assessment of novel dental implant (locally-developed Indonesian 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 II
Assessment
Primary outcomes
The osseontegration of dental implant from clinical (wound healing, soft tissue stability) and dental radiography parameter (bone density, bone to implant contact, bone microstructures)
Key secondary outcomes
The nature of ossoeintegration takes time to observe so the study will be conductred for 4 months after dental implant placement in human alveolar bone
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
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 length is inserted into the site (0,5 mm to 1 mm submerged in alveolar bone) with selected sequences. The neck of dental implant is covered along with the dental implant is conducted so the evaluation of its ossoeintegration 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, 14, 28, days and 16 weeks for clinical and radiography assessment. The result of 16 weeks observation will be determined from clinical and radiography parameters (bone density, bone to implant contact, bone microstructures measurements). The results of these measurements will be compared with the commercial implant group as the control.
Interventions/Control_2
Subjects will have dental implant procedure with standard osteotomy technique for dental implant using selected drilling sequences in posterior mandible. Following osteotomy procedure, the commercial dental implant as a control in this study with the size of 4 mm in diameter and 10 mm length is inserted into the site (0,5 mm to 1 mm submerged in alveolar bone) with selected sequences. The neck of dental implant is covered along with the dental implant is conducted so the evaluation of its ossoeintegration 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, 14, 28, days and 16 weeks for clinical and radiography assessment. The result of 16 weeks observation will be determined from clinical and radiography parameters (bone density, bone to implant contact, bone microstructures measurements)
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. The patient agrees to participate in the study.
2. Male or female patients aged 18 to 54 years.
3. Partially edentulous patients in the right and left posterior mandible who have completed the post-extraction healing period of at least 3 months.
4. Patients with sufficient residual bone volume to allow implant insertion with a diameter of 4 mm and a length of 10 mm.
5. Patients with good oral hygiene control, as indicated by a modified sulcus bleeding index <1 (according to Mombelli et al.) and a plaque index <=20% (according to O Leary).
6. Patients with adequate interocclusal distance (minimum 7 mm) in the edentulous area.
7. Patients with a keratinized mucosa width of >=2 mm.
Key exclusion criteria
1. Patients who smoke.
2. Pregnant or breastfeeding patients.
3. Patients with systemic diseases such as diabetes mellitus, osteoporosis, hypertension, arthritis, hypothyroidism, parathyroidism, or hematologic disorders based on medical history and blood examination.
4. Patients currently taking anti-inflammatory drugs, bisphosphonates, corticosteroids, or hormone replacement therapy (within six months prior to surgery).
5. Patients with a history of bone augmentation in the implant area within the last six months.
6. Patients with a history of tooth extraction in the implant area within the last three months.
7. Patients requiring bone or soft tissue grafting at the time of implant insertion.
8. Patients with physical disabilities that may interfere with their ability to maintain oral hygiene.
9. Patients with a history of radiotherapy in the head and neck region.
10. Patients allergic to local anesthetic agents.
11. Patients with bad oral habits such as bruxism or clenching.
12. Patients with psychosis or other psychiatric disorders.
13. Patients allergic to local anesthetic medications.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aldilla |
| Middle name | |
| Last name | Miranda |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Departement of Periodontics
Zip code
40132
Address
Jalan Sekeloa Selatan No. 1, Lebakgede, Kecamatan Coblong, Kota Bandung
TEL
6281931326726
aldilla.miranda@unpad.ac.id
Public contact
Name of contact person
| 1st name | Sischa |
| Middle name | |
| Last name | Ramadhani |
Organization
Faculty of Dentistry, Universitas Padjadjaran
Division name
Departement of Periodontics
Zip code
40132
Address
Jalan Sekeloa Selatan No. 1, Lebakgede, Kecamatan Coblong, Kota Bandung
TEL
6285273139153
Homepage URL
sischa.ramadhani@yahoo.com
Sponsor or person
Institute
Departement 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
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
250
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
| 2025 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068203
