An interventional study of ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. and 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm in Jaw, Edentulous, Partially, sponsored by Dentsply Sirona Implants and Consumables. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-13.
Sponsored by Dentsply Sirona Implants and Consumables (part of Dentsply Sirona) · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 18 studies in Jaw, Edentulous, Partially by Dentsply Sirona — none open to participants now, 2 under way, none of them phase 3. Jaw, Edentulous, Partially · Dentsply Sirona.
Among the 18 studies in Jaw, Edentulous, Partially by Dentsply Sirona, this one is the 17th largest by enrollment, is the only one that started in 2002, is one of 18 with no phase, and was the 7th registered.
76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.
Browse Jaw, Edentulous, Partially studies →None of the 18 studies in Jaw, Edentulous, Partially by Dentsply Sirona is open now. The open studies under Jaw, Edentulous, Partially, anywhere →
Of the 6 Jaw, Edentulous, Partially studies recruiting now, 4 set no upper age limit and 1 stops at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2002.
This study's enrollment of 36 is close to the median of 38 across 67 interventional studies indexed under Jaw, Edentulous, Partially.
Median enrollment 60 across the 18 interventional studies. Of the 16 that completed or were terminated, 15 (94%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Dentsply Sirona Implants and Consumables, one of the names counted as Dentsply Sirona. Under that name alone:
Dentsply Sirona Implants and Consumables is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Jaw, Edentulous, Partially by Dentsply Sirona, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
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.
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.
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.
Ø 4.5 cm in lengths 9-13 mm
Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
Ø 4.0 cm in lengths 8.5-13 mm
Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Marginal Bone Level Changes
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
Time frame: 3 years after implant placement (baseline)
| Milestone | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants |
|---|---|---|
| Started | 18 | 18 |
| Completed | 15 | 16 |
| Not completed | 3 | 2 |
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
| millimeter | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants |
|---|---|---|
| Marginal Bone Level Changes | -0.25 ± 0.60 | -0.50 ± 0.93 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASTRA TECH Implant System; Fixture ST | — | 1/18 (5.6%) | 0/18 (0%) |
| Biomet 3i; Osseotite® Implants | — | 1/18 (5.6%) | 0/18 (0%) |
| Event | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants |
|---|---|---|
| Advanced breast cancerReproductive system and breast disorders | 0/18 | 1/18 |
| Prostate cancerReproductive system and breast disorders | 1/18 | 0/18 |
| Age, Continuous(years) | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants | Total |
|---|---|---|---|
| Mean | 55 ± 12 | 51 ± 11 | 53 ± 12 |
| Sex: Female, Male(Participants) | ASTRA TECH Implant System; Fixture ST | Biomet 3i; Osseotite® Implants | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 7 | 6 | 13 |
The record gives a start of Dec 2002, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2014, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dentsply Sirona Implants and Consumables →