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A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability

A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability - A Non-Inferiority Randomized Controlled Clinical Trial of a Indonesian-Developed Dental Implant: Evaluation of Osseointegration, Bone Microstructure, Wound Healing, and Soft Tissue Stability

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059625
Enrollment
30
Registered
2025-12-01
Start date
2025-10-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial edentulism of the mandible with no history of smoking and systemic condition

Interventions

Sponsors

Departement of Periodontics, Faculty of Dentistry, Universitas Padjadjaran
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The osseontegration of dental implant from clinical (wound healing, soft tissue stability) and dental radiography parameter (bone density, bone to implant contact, bone microstructures)

Secondary

MeasureTime frame
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

Countries

Asia(except Japan)

Contacts

Public ContactSischa Ramadhani

Faculty of Dentistry, Universitas Padjadjaran Departement of Periodontics

sischa.ramadhani@yahoo.com6285273139153

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026