Trials / Unknown
UnknownNCT04618055
Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants
A Prospective, Open Label, Randomized, Double Arm, Multicenter Study to Evaluate the Performance of NiTiDent Tuah Porous NiTi Dental Implants in Single Tooth Gap in the Posterior Mandible
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Nitium Technology Sdn Bhd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this prospective, open-label, randomized, double arm multicenter study is to evaluate the safety and clinical performance of a newly developed NiTiDent Tuah porous NiTi dental implant (from Nitium Technology Sdn Bhd) in singletooth gap in the posterior mandible 1 year after implant placement and 8 months after implant loading. Second, To investigate the clinical outcome of the interventional dental implant (NiTiDent Tuah Porous NiTi dental implant) compared to control dental implant. The hypothesis is set to no difference in the clinical outcome for the two types of implants based on the outcomes of the primary and secondary endpoints.
Detailed description
The primary endpoint is to assess implant survival rate over a 12-month period. A surviving implant is defined as an integrated implant in the patient's jaw bone at the time of assessment. Secondary endpoints include the assessment of implant stability, crestal bone levels, peri-implant soft tissue conditions, implant success, and patient satisfaction and related outcomes over several intervals within a 12-month period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NiTiDent Tuah Porous NiTi Dental Implants | A newly developed NiTiDent Tuah porous NiTi cylindrical bone level dental implant measuring 4.5 mm in diameter and 10 mm in length and an abutment system of different heights and angulations produced by Nitium Technology Sdn Bhd. |
| DEVICE | Control Dental Implant Systems | A market approved bone level dental implant systems measuring 4.5 mm in diameter and 10 mm in length and an abutment system of different heights and angulations |
Timeline
- Start date
- 2021-10-15
- Primary completion
- 2022-09-15
- Completion
- 2023-04-15
- First posted
- 2020-11-05
- Last updated
- 2022-04-07
Locations
3 sites across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT04618055. Inclusion in this directory is not an endorsement.