Partial-edentulismNCT04618055
Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants
A study testing NiTiDent Tuah Porous NiTi Dental Implants in people with Partial-edentulism, run by Nitium Technology Sdn Bhd at 3 sites in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- NiTiDent Tuah Porous NiTi Dental Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesMalaysia
- Study dates
- 15 Oct 2021to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
- Patient is taking medications or having treatments known to have an effect on bone turnover, including thiazide diuretics, calcitonin, systemic steroids, bisphosphonates, vitamin D (>800 IU/day), estrogen or progesterone therapy.
- History of steroid treatment of duration of 2 weeks or longer in the past 2 years.
- Patient currently undergoing chemotherapy.
- Patient has history of radiation treatment to the head or neck.
- Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis.
- Use of any investigational drug or device within the 30-day period immediately prior to implant surgery.
- Patient is pregnant and lactating.
- Post Implant Surgery:
- Lack of implant primary stability.
- Inappropriate implant position for prosthetic requirements.
- Major simultaneous augmentation procedures at surgery.
- X-ray not showing the implant from first bone contact to apical tip.
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites, 3 recruiting
- Recruiting
Faculty of Dentistry, Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, 50300
Ho Ting Khee, DDS, 6038921 5555, tingkhee.ho@ukm.edu.my
Ho Ting Khee, DDS
- Recruiting
Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
Prema Sukumaran, BDS, 60379674863, prema@um.edu.my
Prema Sukumaran, BDS
- Recruiting
Faculty of Dentistry, Universiti Teknologi MARA
Sungai Buloh, Selangor, 47000
Siti Mariam Abd Ghani, BDS, 60361266611, sitimariam783@uitm.edu.my
Siti Mariam Abd Ghani, BDS
About this study
Official title: 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
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.
Read the 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
- Partial-edentulism
- Being tested
- NiTiDent Tuah Porous NiTi Dental Implants, Control Dental Implant Systems
- Keywords
- Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiTiDent Tuah Porous NiTi Dental ImplantsDevice
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.
Control Dental Implant SystemsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| NiTiDent Tuah Porous NiTi Dental Implants | Experimental | Not described Receives: Device: NiTiDent Tuah Porous NiTi Dental Implants |
| Control Implant | Active comparator | Not described Receives: Device: Control Dental Implant Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
Measured: 12-month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start15 Oct 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitium Technology Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lim Tong Wah, BDS, Principal investigator, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618055
- Sponsor's protocol ID
- NTSB/MD/01-01-CIP-01 version 1
- Status last verified
- Apr 2022
- First submitted
- 2 Nov 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04618055
- Acronym / sponsor ID
- NTSB/MD/01-01-CIP-01 version 1
- Conditions
- Partial-edentulism
- Keywords
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Nitium Technology Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NiTiDent Tuah Porous NiTi Dental Implants | Experimental | Device: NiTiDent Tuah Porous NiTi Dental Implants |
| Control Implant | Active comparator | Device: Control Dental Implant Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (27 listed)
- Presurgical
- Post Implant Surgery:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiTiDent Tuah Porous NiTi Dental ImplantsA 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 | NiTiDent Tuah Porous NiTi Dental Implants |
| Control Dental Implant SystemsA 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 | Device | Control Implant |
Primary outcome
Implant survival
Time frame: 12-month
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
4 secondary outcomes
Assess Implant Stability (Resonance Frequency Values)
Time frame: Day 0 (Baseline), week 18, week 36 and week 52
Crestal Bone Levels Evaluation
Time frame: Day 0 (Baseline), week 22, week 36 and week 52
Peri-Implant Soft Tissues Evaluation
Time frame: Week 22, week 36 and week 52
Implant Success Evaluation
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Related trials for Partial-edentulism
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lim Tong Wah, BDS principal investigator
Universiti Teknologi Mara
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NiTiDent Tuah Porous NiTi Dental Implants in people with Partial-edentulism, run by Nitium Technology Sdn Bhd at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asif A. Khushaini (60167733360, asif@nitiumtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.