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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
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.
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
Faculty of Dentistry, Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
RECRUITINGFaculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
RECRUITINGFaculty of Dentistry, Universiti Teknologi MARA
Sungai Buloh, Selangor, Malaysia
RECRUITINGImplant survival
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
Time frame: 12-month
Assess Implant Stability (Resonance Frequency Values)
The measurement of Implant stability quotient (ISQ) value that indicates the level of stability and osseointegration in dental implants at the time of implant placement (Day 0 - 1st visit) and at 18 weeks (3rd visit), 36 weeks (5th visit) and 52 weeks (6th visit) after implant placement.
Time frame: Day 0 (Baseline), week 18, week 36 and week 52
Crestal Bone Levels Evaluation
The mesial and distal bone levels will be measured at baseline (during implant placement, Day 0 - 1st visit), at 22 weeks (during placement of the crown - 4th visit), 36 weeks (5th visit) and 52 weeks (6th visit) post implant placement by means of a single reader on standardized periapical radiographs.
Time frame: Day 0 (Baseline), week 22, week 36 and week 52
Peri-Implant Soft Tissues Evaluation
The conditions of the peri-implant soft tissues will be evaluated by probing depth, bleeding on probing, suppuration and dehiscence at 22-week (4th visit), 36-week (5th visit) and 52-week (6th visit) follow-up visit.
Time frame: Week 22, week 36 and week 52
Implant Success Evaluation
Evaluation of implant success as assessed in the absence of post-surgery complications and other adverse events.
Time frame: 12-month
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