Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059625) titled 'A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Departement of Periodontics, Faculty of Dentistry, Universitas Padjadjaran

Condition: Condition - Partial edentulism of the mandible with no history of smoking and systemic condition Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

Eligibility: Age-lower limit - 18 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 =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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068203

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