A Phase 4 interventional study of NobelReplace S-TiUltra and NobelReplace TiUnite in Missing Tooth/Teeth, sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
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.
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: NobelReplace TiUnite
Device: NobelReplace S-TiUltra
NobelReplace S-TiUltra dental implant placed according to the manufacturer's recommended surgical protocol.
NobelReplace TiUnite dental implant placed according to the manufacturer's recommended surgical protocol.
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.
Time frame: Day 0 (implant placement) and Weeks 2, 4, 6, 8, and 12
Mean Implant Insertion Torque (Ncm)
Insertion torque will be recorded during implant placement and expressed in Newton-centimeters (Ncm).
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 (implant placement) through Week 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Anodontia
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