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Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants

NCT04618055 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-04-07

No results posted yet for this study

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.

Conditions

  • Partial-edentulism

Interventions

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

Sponsors & Collaborators

  • Nitium Technology Sdn Bhd

    lead INDUSTRY

Principal Investigators

  • Lim Tong Wah, BDS · Universiti Teknologi Mara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-09-15
Completion
2023-04-15

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618055 on ClinicalTrials.gov