Prostheses and ImplantsNCT02444962
BioComp Implants in Anaplastology - Pilot Study
A study testing HAVD-implant in people with Prostheses and Implants and Craniofacial Defects, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Prostheses and Implants, Craniofacial Defects
- What is being tested?
- HAVD-implant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2018to 31 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In need of an auricular, nasal or orbital episthesis
- Be able to maintain a good personal hygiene
Who cannot join
- Contraindications for general anesthesia
- DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene
- Poor personal hygiene
- Pregnancy
- Acute infection
- Immunosuppression
- Compromised by medication
- Local irradiation >50Gray
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
MaastrichtUMC
Maastricht, Limburg, 6229HX
Peter Kessler, MD PhD
About this study
Official title: Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects
At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life.
Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions.
Read more
Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient.
The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.
- Conditions
- Prostheses and Implants, Craniofacial Defects
- Being tested
- HAVD-implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAVD-implantDevice
hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis
| Study group | Role | What they receive |
|---|---|---|
| HAVD implant | Experimental | Not described Receives: Device: HAVD-implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in implant stability as measured by the Osstell implant stability meter at one year
Measured: one year
Secondary outcomes (9)
redness/irritation of the skin
Measured: baseline
redness/irritation of the skin
Measured: 12 weeks after implant placement
redness/irritation of the skin
Measured: 26 weeks after implant placement
redness/irritation of the skin
Measured: 52 weeks after implant placement
Implant survival
Measured: 52 weeks after implant placement
Clinical ease of use
Opinion of the surgeon about the easiness of use of the implant system, scored by a questionnaire.
Measured: Directly after implant placement (0)
Patient satisfaction as measured by a VAS scoring system
Patient satisfaction scored by a self made questionnaire
Measured: 26 weeks after implant placement
Patient satisfaction as measured by a VAS scoring system
Patient satisfaction scored by a self made questionnaire
Measured: 52 weeks after implant placement
Quality of life a measured by a VAS scoring system
Quality of life scored by a self made questionnaire
Measured: 52 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostheses and ImplantsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter AW Kessler, Prof. Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444962
- Sponsor's protocol ID
- METC142065
- Status last verified
- Nov 2018
- First submitted
- 22 Dec 2014
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects
- ClinicalTrials.gov ID
- NCT02444962
- Acronym / sponsor ID
- METC142065
- Conditions
- Prostheses and Implants, Craniofacial Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 May 2015 (estimated)
- 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.
At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life.
Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions.
Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient.
The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAVD implant | Experimental | Device: HAVD-implant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In need of an auricular, nasal or orbital episthesis
- Be able to maintain a good personal hygiene
Key exclusion criteria (8 listed)
- Contraindications for general anesthesia
- DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene
- Poor personal hygiene
- Pregnancy
- Acute infection
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 |
|---|---|---|
| HAVD-implanthydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis | Device | HAVD implant |
Primary outcome
Changes in implant stability as measured by the Osstell implant stability meter at one year
Time frame: one year
9 secondary outcomes
redness/irritation of the skin
Time frame: baseline
redness/irritation of the skin
Time frame: 12 weeks after implant placement
redness/irritation of the skin
Time frame: 26 weeks after implant placement
redness/irritation of the skin
Time frame: 52 weeks after implant placement
Implant survival
Time frame: 52 weeks after implant placement
Clinical ease of use
Time frame: Directly after implant placement (0)
Patient satisfaction as measured by a VAS scoring system
Time frame: 26 weeks after implant placement
Patient satisfaction as measured by a VAS scoring system
Time frame: 52 weeks after implant placement
Quality of life a measured by a VAS scoring system
Time frame: 52 weeks after implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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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.
Peter AW Kessler, Prof. Dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAVD-implant in people with Prostheses and Implants and Craniofacial Defects, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Nov 2018. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronique CM Timmer, Msc (+31433872010, v.timmer@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in implant stability as measured by the Osstell implant stability meter at one year (time frame: one year). 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 27 Nov 2018.