Healthy SubjectsNCT05805033
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
A study testing Mucointegration in people with Healthy Subjects, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Mucointegration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Sep 2023to 1 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants have to voluntarily sign the informed consent form before any study related action
- Patients aged 18 or over
- Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
- Men/women
- Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
- Patients requiring a replacement of missing teeth; the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation
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- At least 3 mm of fibrous mucosa in the bucco-lingual dimension
- Full mouth plaque score (FMPI) lower than or equal to 25%
- At least a diameter of 4 mm for the implant (regular diameter)
Who cannot join
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonates intravenously or more than 3 years of oral use
- Infection (local or systemic) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
- Current pregnancy or breastfeeding women
- Alcoholism or chronical drug abuse
Show all 12Show fewer
- Immunocompromised patients
- Uncontrolled diabetes
- Smokers
- Prisoners
- Implant's diameter under 4 mm (narrow implant)
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of the study or interference with analysis of study results, such as history of non-compliance, or unreliability
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Clémentine Canuel
Liège, 4000
Clémentine Canuel, MsD, +33679097264, clementine.canuel@hotmail.fr
About this study
The purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.
Read the detailed description
After being informed about the study and potential risks, all participants give written informed consent and eligibility for study entry.
The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.
After 8 weeks of healing, biopsy are separated in two groups according to the removal:
- if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
- if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment
- Conditions
- Healthy Subjects
- Being tested
- Mucointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucointegrationOther
Placement of abutment on a dental implant to study mucointegration
| Study group | Role | What they receive |
|---|---|---|
| Ultra-polished zirconia abutment | Experimental | Not described Receives: Other: Mucointegration |
| Machined zirconia abutment | Experimental | Not described Receives: Other: Mucointegration |
| Titanium abutment | Active comparator | Not described Receives: Other: Mucointegration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometry
Height measure of biological width (sulcus depth, epithelial and connective adhesion)
Measured: 8 weeks of healing
Immunohistology
Analysis of the pro-inflammatory cells and vascularisation of the soft tissue + analysis of the percentage of cells adhesion on the abutment
Measured: 8 weeks of healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start22 Sep 2023
- Primary completion18 Jun 2024
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clémentine CANUEL, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805033
- Sponsor's protocol ID
- 2022/189
- Other IDs
- B7072022000023
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Soft Tissue Integration in Humans: Influence of Material
- ClinicalTrials.gov ID
- NCT05805033
- Acronym / sponsor ID
- 2022/189
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Apr 2023 (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 purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.
Detailed description
After being informed about the study and potential risks, all participants give written informed consent and eligibility for study entry.
The day of the surgery, patients will be randomized in machined zirconia or ultra-polished zirconia.
After 8 weeks of healing, biopsy are separated in two groups according to the removal:
- if the abutment come together with the surrounding soft tissues, it goes for a non decalcified histology for histometric measurements to determine the dimensions of biological width (sulcus depth, epithelial and connective adhesion)
- if the abutment come separate of the surrounding tissue, the soft tissue goes for immunohistochemistry to analyse pro-inflammatory cells and vascularisation and the abutment for SEM analysis to calculate the percentage of adhesion of the cells on the abutment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultra-polished zirconia abutment | Experimental | Other: Mucointegration |
| Machined zirconia abutment | Experimental | Other: Mucointegration |
| Titanium abutment | Active comparator | Other: Mucointegration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants have to voluntarily sign the informed consent form before any study related action
- Patients aged 18 or over
- Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
- Men/women
- Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
Key exclusion criteria (12 listed)
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonates intravenously or more than 3 years of oral use
- Infection (local or systemic) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
- Current pregnancy or breastfeeding women
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 |
|---|---|---|
| MucointegrationPlacement of abutment on a dental implant to study mucointegration | Other | Machined zirconia abutment, Titanium abutment, Ultra-polished zirconia abutment |
Primary outcome
Histomorphometry
Time frame: 8 weeks of healing
Height measure of biological width (sulcus depth, epithelial and connective adhesion)
Immunohistology
Time frame: 8 weeks of healing
Analysis of the pro-inflammatory cells and vascularisation of the soft tissue + analysis of the percentage of cells adhesion on the abutment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucointegration in people with Healthy Subjects, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 9 inclusion and 12 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 5 Sep 2024. 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 Belgium. 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 Clémentine Canuel, MsD (+33679097264, clementine.canuel@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histomorphometry (time frame: 8 weeks of healing). 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 5 Sep 2024.