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NCT01541345
A Phase III, Randomized, Controlled Clinical Trial of Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2
Phase 3 trial testing Autogenous bone graft in Missing Teeth in 24 participants. Completed in 4 June 2019.
25 April 2014
Quick facts
| Lead sponsor | University of Zurich |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 24 |
| Start date | 1 February 2011 |
| Primary completion | 25 April 2014 |
| Estimated completion | 4 June 2019 |
| Sites | 2 locations across Austria, Switzerland |
Drugs / interventions tested
- Autogenous bone graft — full drug profile →
- InductOs (DIBOTERMIN ALFA) — full drug profile →
- Augmentation surgery
Conditions studied
- Missing Teeth — all drugs for Missing Teeth →
Sponsor
University of Zurich
Who can join
Adults 20 to 75, any sex, with Missing Teeth. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bone quality/quantity
Time frame: 4 month after augmentation surgery
Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient).
Sponsor's own description
Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed. The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects. The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01541345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Autogenous bone graft
Trials testing the same drug.
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Other recruiting trials for Missing Teeth
Currently open trials in the same condition.
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- NCT04581304 — The Use of Bio-Oss Collagen for Sinus Augmentation Using the Transcrestal Approach. · NA · active not recruiting
- NCT04741906 — Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication · recruiting
Other University of Zurich trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01541345 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Zurich
- Last refreshed: 21 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01541345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing