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NCT03978962
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
trial testing Guided Tissue Regeneration in Oral Bone Defect in 56 participants. Completed in 26 August 2020.
26 August 2020
Quick facts
| Lead sponsor | Biomatlante |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 56 |
| Start date | 28 May 2019 |
| Primary completion | 26 August 2020 |
| Estimated completion | 26 August 2020 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Guided Tissue Regeneration
Conditions studied
- Oral Bone Defect — all drugs for Oral Bone Defect →
- Maxillofacial Bone Defect — all drugs for Maxillofacial Bone Defect →
- Periodontal Bone Loss — all drugs for Periodontal Bone Loss →
- Alveolar Bone Loss — all drugs for Alveolar Bone Loss →
Sponsor
Biomatlante
Who can join
Adults 18 to 70, any sex, with Oral Bone Defect or Maxillofacial Bone Defect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The evaluation of the clinical data has demonstrated the conformity of the Resorbable Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in periodontal applications. The RCM is intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures. It acts as a barrier against the migration of epithelial cells within the bone defect (performance) and thus complies with several surgical indications in the treatment of maxillofacial bone defects. It has been concluded that the risks associated with the use of this device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the RCM, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters: 1. Tissue regeneration (mucosa health on the site of implantation) 2. Safety (report of any adverse event) 3. Radiographic analysis of periodontal tissues
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 NCT03978962
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Guided Tissue Regeneration
Trials testing the same drug.
- NCT05756946 — Guided Tissue Regeneration With a Periodontal Dressing · NA · completed
Other Biomatlante trials
Trials by the same sponsor.
- NCT04122677 — Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions · completed
- NCT04076956 — Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions · completed
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 NCT03978962 (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 Biomatlante
- Last refreshed: 4 February 2025
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/NCT03978962.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing