Edentulous Alveolar RidgeNCT04543292
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
A study testing MATFILL (PTFE) in people with Edentulous Alveolar Ridge, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- MATFILL (PTFE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 6 Nov 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Clinical need for the placement of a implant-supported dental prosthesis
- Clinical need for the filling of the prosthetic chimney
- Signing informed consent
Who cannot join
- Inability of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- MATFILL (PTFE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATFILL (PTFE)Device
Filling of the prosthetic chimney with the compressed material
| Study group | Role | What they receive |
|---|---|---|
| MATFILL | Experimental | Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head. Receives: Device: MATFILL (PTFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of screw head
Integrity of the screw head observed in photographs
Measured: 6 weeks
Integrity of screw head
Retightening after screw after unscrew
Measured: 6 weeks
Secondary outcomes (2)
Occurrence of prosthetic complications
Occurrence of prosthetic complications during follow-up
Measured: 6 weeks
Occurrence of biological complications
Occurrence of biological complications
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Sep 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Collaborators
- BTI Biotechnology Institute
- Responsible party
- Sponsor
- Investigators
- Eduardo Anitua, MD, DDS, PhD, Principal investigator, Eduardo Anitua Private Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543292
- Sponsor's protocol ID
- BTI_01_EP/20/MATFILL
- Other IDs
- Exp. 812/20/EC
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 16 Jun 2021
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
- ClinicalTrials.gov ID
- NCT04543292
- Acronym / sponsor ID
- BTI_01_EP/20/MATFILL
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Collaborators
- BTI Biotechnology Institute
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 10 Sep 2020 (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.
Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MATFILL | Experimental | Device: MATFILL (PTFE)Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Clinical need for the placement of a implant-supported dental prosthesis
- Clinical need for the filling of the prosthetic chimney
- Signing informed consent
Key exclusion criteria (1 listed)
- Inability of follow-up
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 |
|---|---|---|
| MATFILL (PTFE)Filling of the prosthetic chimney with the compressed material | Device | MATFILL |
Primary outcome
Integrity of screw head
Time frame: 6 weeks
Integrity of the screw head observed in photographs
Integrity of screw head
Time frame: 6 weeks
Retightening after screw after unscrew
2 secondary outcomes
Occurrence of prosthetic complications
Time frame: 6 weeks
Occurrence of biological complications
Time frame: 6 weeks
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 16 Jun 2021.
- 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.
Eduardo Anitua, MD, DDS, PhD principal investigator
Eduardo Anitua Private Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MATFILL (PTFE) in people with Edentulous Alveolar Ridge, run by Fundación Eduardo Anitua at 1 site in Spain.
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 4 inclusion and 1 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Integrity of screw head (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 16 Jun 2021.