Missing Tooth/TeethPhase 4NCT07911319
S-TiUltra Implant Study
A Phase 4 study testing NobelReplace S-TiUltra and NobelReplace TiUnite in people with Missing Tooth/Teeth, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This prospective clinical study will compare early healing and implant stability between two Nobel Biocare dental implant systems, NobelReplace S-TiUltra and NobelReplace CC TiUnite. Approximately 30 implants will be randomly assigned to one of the two implant groups and followed for 12 weeks after placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Missing Tooth/Teeth
- What is being tested?
- NobelReplace S-TiUltra and NobelReplace TiUnite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Male or Female
- Partially edentulous patients
- Healed ridges (≥3 months post-extraction with no history of socket preservation or ridge augmentation)
- Adequate bone volume (no need for major grafting)
- Sites requiring a single unit implant
- Provision of informed consent
Who cannot join
- Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1C > 8.0 within last six months
- Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
- History of osseous degenerative diseases
- Heavy smoking (>10 cigarettes/day)
- Bisphosphonate/antiresorptive therapy
- uncontrolled periodontal disease
Show all 9Show fewer
- Irradiated bone
- Previous history of failed implants
- Recently grafted/augmented site (< 1 year)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21231
About this study
Official title: Comparison of Early Healing Dynamics Between Nobel Biocare TiUnite and the Novel S TiUltra Implants Using Resonance Frequency Analysis: A Prospective Clinical Study
This prospective clinical study will compare early healing and implant stability between two Nobel Biocare dental implant systems, NobelReplace S-TiUltra and NobelReplace CC TiUnite. Approximately 30 implants will be randomly assigned to one of the two implant groups and followed for 12 weeks after placement. Implant stability will be assessed using resonance frequency analysis at implant placement and at approximately 2, 4, 6, 8, and 12 weeks. Clinical healing, radiographic findings, and other treatment-related outcomes will also be evaluated during the follow-up period.
- Conditions
- Missing Tooth/Teeth
- Being tested
- NobelReplace S-TiUltra, NobelReplace TiUnite
- Keywords
- Dental Implant
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelReplace S-TiUltraDevice
NobelReplace S-TiUltra dental implant placed according to the manufacturer's recommended surgical protocol.
NobelReplace TiUniteDevice
NobelReplace TiUnite dental implant placed according to the manufacturer's recommended surgical protocol.
| Study group | Role | What they receive |
|---|---|---|
| TiUnite | Active comparator | Not described Receives: Device: NobelReplace TiUnite |
| S-TiUltra | Experimental | Not described Receives: Device: NobelReplace S-TiUltra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Implant Stability Quotient (ISQ) Measured by Resonance Frequency Analysis (RFA)
Implant stability will be assessed using an Osstell device/SmartPeg transducer expressed as Implant Stability Quotient (ISQ) values on a scale of 0 to 100. Longitudinal changes in ISQ will be compared between the TiUnite and S-TiUltra implant groups over the 12-week healing period to evaluate differences in implant stability trajectories.
Measured: Day 0 (implant placement) and Weeks 2, 4, 6, 8, and 12
Secondary outcomes (3)
Mean Implant Insertion Torque (Ncm)
Insertion torque will be recorded during implant placement and expressed in Newton-centimeters (Ncm).
Measured: Day 0 (during implant placement)
Change From Baseline in Radiographic Marginal Bone Level (mm)
Marginal bone levels in millimeters (mm) will be assessed using standardized periapical radiographs obtained at implant placement (baseline) and at 6 and 12 weeks after surgery.
Measured: Day 0 (baseline) and Weeks 6 and 12
Number of Participants With Implant Failure
Implant-related complications, including implant failure and marginal bone loss, will be assessed during the 12-week follow-up period.
Measured: From Day 0 (implant placement) through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing Tooth/TeethStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanae Saito, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911319
- Sponsor's protocol ID
- HP-00120517
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Healing Dynamics Between Nobel Biocare TiUnite and the Novel S TiUltra Implants Using Resonance Frequency Analysis: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07911319
- Acronym / sponsor ID
- HP-00120517
- Conditions
- Missing Tooth/Teeth
- Keywords
- Dental Implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
This prospective clinical study will compare early healing and implant stability between two Nobel Biocare dental implant systems, NobelReplace S-TiUltra and NobelReplace CC TiUnite. Approximately 30 implants will be randomly assigned to one of the two implant groups and followed for 12 weeks after placement. Implant stability will be assessed using resonance frequency analysis at implant placement and at approximately 2, 4, 6, 8, and 12 weeks. Clinical healing, radiographic findings, and other treatment-related outcomes will also be evaluated during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TiUnite | Active comparator | Device: NobelReplace TiUnite |
| S-TiUltra | Experimental | Device: NobelReplace S-TiUltra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Male or Female
- Partially edentulous patients
- Healed ridges (≥3 months post-extraction with no history of socket preservation or ridge augmentation)
- Adequate bone volume (no need for major grafting)
Key exclusion criteria (9 listed)
- Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1C > 8.0 within last six months
- Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
- History of osseous degenerative diseases
- Heavy smoking (>10 cigarettes/day)
- Bisphosphonate/antiresorptive therapy
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 |
|---|---|---|
| NobelReplace S-TiUltraNobelReplace S-TiUltra dental implant placed according to the manufacturer's recommended surgical protocol. | Device | S-TiUltra |
| NobelReplace TiUniteNobelReplace TiUnite dental implant placed according to the manufacturer's recommended surgical protocol. | Device | TiUnite |
Primary outcome
Mean Implant Stability Quotient (ISQ) Measured by Resonance Frequency Analysis (RFA)
Time frame: Day 0 (implant placement) and Weeks 2, 4, 6, 8, and 12
Implant stability will be assessed using an Osstell device/SmartPeg transducer expressed as Implant Stability Quotient (ISQ) values on a scale of 0 to 100. Longitudinal changes in ISQ will be compared between the TiUnite and S-TiUltra implant groups over the 12-week healing period to evaluate differences in implant stability trajectories.
3 secondary outcomes
Mean Implant Insertion Torque (Ncm)
Time frame: Day 0 (during implant placement)
Change From Baseline in Radiographic Marginal Bone Level (mm)
Time frame: Day 0 (baseline) and Weeks 6 and 12
Number of Participants With Implant Failure
Time frame: From Day 0 (implant placement) through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NobelReplace S-TiUltra and NobelReplace TiUnite in people with Missing Tooth/Teeth, run by University of Maryland, Baltimore at 1 site in United States.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanae Saito (410-706-3646, hsaito@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Implant Stability Quotient (ISQ) Measured by Resonance Frequency Analysis (RFA) (time frame: Day 0 (implant placement) and Weeks 2, 4, 6, 8, and 12). 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 2 Nov 2026; AzTrials last refreshed its copy on 2 Nov 2026.