Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants

NCT04618055 | Unknown

• 1 other identifier: NTSB/MD/01-01-CIP-01 version 1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Dental Implant

Outcome Measures

Primary Outcomes (1)

• Implant survival

  A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

  12-month

Secondary Outcomes (4)

• Assess Implant Stability (Resonance Frequency Values)

  Day 0 (Baseline), week 18, week 36 and week 52

• Crestal Bone Levels Evaluation

  Day 0 (Baseline), week 22, week 36 and week 52

• Peri-Implant Soft Tissues Evaluation

  Week 22, week 36 and week 52

• Implant Success Evaluation

  12-month

Other Outcomes (2)

• Patient Satisfaction

  Week 52

• Patient Related Outcome

  Day 0 (Baseline) and week 52

Study Arms (2)

NiTiDent Tuah Porous NiTi Dental Implants

EXPERIMENTAL

Device: NiTiDent Tuah Porous NiTi Dental Implants

Control Implant

ACTIVE COMPARATOR

Device: Control Dental Implant Systems

Interventions

NiTiDent Tuah Porous NiTi Dental Implants DEVICE

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.

NiTiDent Tuah Porous NiTi Dental Implants

Control Dental Implant Systems DEVICE

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

Control Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex and at least 18 years of age.
• Ability to understand and provide informed consent before starting the study.
• Ability and willingness to comply with all study requirements to be evaluated for each study visit.
• The patient, if of child-bearing potential, has a negative urine pregnancy test.
• Adequate oral hygiene to allow for implant therapy consistent with standards of care.
• Adequate bone volume to accommodate the planned endosseous dental implant placement of 4.5 mm in diameter and 10 mm in length.
• Adequate interocclusal distance (crown height space) of at least 6 mm measured from the alveolar crest to the occlusal table.
• Intact buccal table as verified by Cone Beam Computed Tomography (CBCT). If absent, patient should be excluded from enrollment in the study.
• One tooth in the posterior mandible (first or second molar) planned to be restored with a dental implant as determined by the patient's dental provider.
• The site to be treated is surrounded by two natural teeth (one anterior and one posterior to it).
• Primary stability of implant consistent with standards of care is achieved at the time of implant placement. Minimum primary stability, insertion torque at the value stated in the implants's Instructions for Use (IFU) (this will be a criterion that is met at the time of surgery).
• Patients must be physically able to tolerate conventional surgical and restorative procedures.
• Presence of opposing dentition with a functional occlusion.

You may not qualify if:

• Presurgical
• Patient reports tobacco uses within the last five years. Tobacco use for this study is defined as a current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or tobacco chewing use.
• History of alcoholism or drug abuse within the past 5 years.
• Severe wear with an etiology of bruxism or clenching habits.
• Patients in need of bone grafting at the site of the intended implantation site.
• Patients who have previously failed implants at the site intended for study implant placement.
• Patients in need of other treatments or surgeries at a site adjacent to the intended implantation site.
• Patients with active infection or severe inflammation in the areas intended for implant placement.
• Patient has significant untreated periodontal disease, severe recession, caries, clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
• History of HIV infection, Hepatitis B or C.
• Patients has history of systemic disease that precludes standard dental implant therapy or alters daily activities to a level consistent with ASA (American Society of Anesthesiologists) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
• Presence of local inflammation or mucosal diseases such as lichen planus.
• Patient has history of consistent with high risk for subacute bacterial endocarditis.
• Current hematological disorder or warfarin (or similar) therapy.
• Patient has history of disease that affects bone metabolism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease.

Sponsors & Collaborators

• Nitium Technology Sdn Bhd: lead

Study Sites (3)

Faculty of Dentistry, Universiti Kebangsaan Malaysia

Kuala Lumpur, Kuala Lumpur, 50300, Malaysia

RECRUITING

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Faculty of Dentistry, Universiti Teknologi MARA

Sungai Buloh, Selangor, 47000, Malaysia

RECRUITING

Study Officials

• Lim Tong Wah, BDS

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asif A. Khushaini

CONTACT

60167733360; asif@nitiumtech.com

Rohana Ahmad, BDS, PhD

CONTACT

60361266619; drrohana@uitm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: October 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: April 15, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

MY (3)