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NCT04618055
Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants
NA trial testing NiTiDent Tuah Porous NiTi Dental Implants in Partial-edentulism in 105 participants. Status unknown.
15 September 2022
Quick facts
| Lead sponsor | Nitium Technology Sdn Bhd |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 15 October 2021 |
| Primary completion | 15 September 2022 |
| Estimated completion | 15 April 2023 |
| Sites | 3 locations across Malaysia |
Drugs / interventions tested
- NiTiDent Tuah Porous NiTi Dental Implants
- Control Dental Implant Systems
Conditions studied
- Partial-edentulism — all drugs for Partial-edentulism →
Sponsor
Nitium Technology Sdn Bhd
Who can join
18 and older, any sex, with Partial-edentulism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04618055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT04695899 — Zirconia Implants for Replacement of a Single Tooth · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04618055 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nitium Technology Sdn Bhd
- Last refreshed: 7 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04618055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing