Oral Bone DefectNCT03978962
Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
An observational study of Oral Bone Defect and Maxillofacial Bone Defect, run by Biomatlante at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Bone Defect, Maxillofacial Bone Defect, Periodontal Bone Loss
- What is being tested?
- Guided Tissue Regeneration
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 56 participants
- Where
- 2 sitesFrance
- Study dates
- 28 May 2019to 26 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The group will be selected in the entire population of the dental care center
Who may be able to join
- Male or female aged from 18 to 70
- Periodontal defects (e.g. cyst, bone tumour, crest augmentation...)
- Aleveolar bone defect after tooth (teeth) extraction
- Non opposition form (consent of the patient)
- Patients affiliated to the French social security
- Patients not under guardianship or judicial protection
Who cannot join
- Pregnancy of breastfeeding women
- Severe smoker (>10 cigarettes per day)
- Acute infections
- Allergies to the material (if an allergy of any kind is suspected, adequate exams must be carried out in advance)
- Refusal of the patient to adhere to surgical follow-up and to the limit in activity level
- Fever and/or local inflammation
Show all 14Show fewer
- HIV positive known
- History of uncontrolled diabetes (untreated or not stabilized by treatment)
- History of treatments for previous corticosteroids, long-term (more than 6 months) and interrupted for less than 3 months
- History of chemotherapy in progress or during the last three months
- History of cervico-facial radiotherapy
- History of bone disease with disorders of blood circulation which is defined as Akbers-Schönberg disease or Paget's disease
- Known severe hyperparathyroïdism
- History of severe immune deficiency
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes
Nantes, 44093
Cabinet privé du Dr. S. Kimakhe
Nantes, 44200
About this study
Official title: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures
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:
- Tissue regeneration (mucosa health on the site of implantation)
- Safety (report of any adverse event)
- Radiographic analysis of periodontal tissues
- Being tested
- Guided Tissue Regeneration
- Keywords
- Periodontal defects, Alveolar bone preservation, Collagen membrane, Mucosa healing
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Tissue RegenerationDevice
Also called Guided Bone Regeneration
Covering oral-maxillofacial or a periodontal defects with the Resorbable Collagen Membrane in order to avoid epithelial cell infiltration and to promote periodontal tissues healing.
Covering alveolar bone defects after tooth-teeth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure Receives: Device: Guided Tissue Regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
Observation of the change of the mucosa health in terms of swelling, wound closure and colour of the implantation site. It reflects the performance of the Resorbable Collagen Membrane
Measured: 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)
Secondary outcomes (2)
Number and precise description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the Resorbable Collagen Membrane
Measured: From screening visit through visit at 12 weeks
Percentage of bone reconstruction in the treated bone defect by a radiographic examination
Comparison of the radiographies recorded before surgery and at the last follow-up visit
Measured: Before surgery and 12 weeks post-surgery (+/-1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start28 May 2019
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Bone DefectStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomatlante
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Responsible party
- Sponsor
- Investigators
- Saïd Kimakhe, PhD, DDS, Principal investigator, Centre Hospitalo-Universitaire de NantesSaïd Kimakhe, Phd, DDS, Principal investigator, Cabinet privéGuy Daculsi, PhD, Study director, Biomatlante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978962
- Sponsor's protocol ID
- RE-DT04-18A
- Other IDs
- 2018-A03202-53
- Status last verified
- Feb 2025
- First submitted
- 7 May 2019
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures
- ClinicalTrials.gov ID
- NCT03978962
- Acronym / sponsor ID
- RE-DT04-18A
- Keywords
- Periodontal defects, Alveolar bone preservation, Collagen membrane, Mucosa healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BiomatlanteIndustry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Study start
- 28 May 2019 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 7 Jun 2019 (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.
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:
- Tissue regeneration (mucosa health on the site of implantation)
- Safety (report of any adverse event)
- Radiographic analysis of periodontal tissues
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Device: Guided Tissue RegenerationPatients subjects to a Guided Tissue Regeneration or Guided Bone Regeneration procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The group will be selected in the entire population of the dental care center
Key inclusion criteria (6 listed)
- Male or female aged from 18 to 70
- Periodontal defects (e.g. cyst, bone tumour, crest augmentation...)
- Aleveolar bone defect after tooth (teeth) extraction
- Non opposition form (consent of the patient)
- Patients affiliated to the French social security
Key exclusion criteria (14 listed)
- Pregnancy of breastfeeding women
- Severe smoker (>10 cigarettes per day)
- Acute infections
- Allergies to the material (if an allergy of any kind is suspected, adequate exams must be carried out in advance)
- Refusal of the patient to adhere to surgical follow-up and to the limit in activity level
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 |
|---|---|---|
| Guided Tissue RegenerationAlso: Guided Bone RegenerationCovering oral-maxillofacial or a periodontal defects with the Resorbable Collagen Membrane in order to avoid epithelial cell infiltration and to promote periodontal tissues healing. Covering alveolar bone defects after tooth-teeth extraction. | Device | Study population |
Primary outcome
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection)
Time frame: 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)
Observation of the change of the mucosa health in terms of swelling, wound closure and colour of the implantation site. It reflects the performance of the Resorbable Collagen Membrane
2 secondary outcomes
Number and precise description of any adverse event during the follow-up
Time frame: From screening visit through visit at 12 weeks
Percentage of bone reconstruction in the treated bone defect by a radiographic examination
Time frame: Before surgery and 12 weeks post-surgery (+/-1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- 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. This study is not recruiting at the moment.
Saïd Kimakhe, PhD, DDS principal investigator
Centre Hospitalo-Universitaire de Nantes
Saïd Kimakhe, Phd, DDS principal investigator
Cabinet privé
Guy Daculsi, PhD study director
Biomatlante
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Bone Defect and Maxillofacial Bone Defect, run by Biomatlante at 2 sites in France.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the patient's mucosa health in terms of swelling, wound closure and colour of the implantation site (visual inspection) (time frame: 1 week post-surgery (+/-2 days) / 2 weeks post-surgery (+/-2 days) / 12 weeks post-surgery (+/-1 week)). 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 4 Feb 2025.