Peri-Implant Soft Tissue Integration in Humans: Influence of Material
NCT ID: NCT05805033
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-09-22
2024-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ultra-polished zirconia abutment
Mucointegration
Placement of abutment on a dental implant to study mucointegration
Machined zirconia abutment
Mucointegration
Placement of abutment on a dental implant to study mucointegration
Titanium abutment
Mucointegration
Placement of abutment on a dental implant to study mucointegration
Interventions
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Mucointegration
Placement of abutment on a dental implant to study mucointegration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Liege
OTHER
Responsible Party
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Clémentine CANUEL
2nd year resident in periodontology, oral and implant surgery
Locations
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Clémentine Canuel
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B7072022000023
Identifier Type: OTHER
Identifier Source: secondary_id
2022/189
Identifier Type: -
Identifier Source: org_study_id
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