Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.
NCT ID: NCT01620918
Last Updated: 2021-12-01
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-08-31
2015-08-31
Brief Summary
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* Standard preparation of the osteotomy
* Placement of 2 dental implants
* On each implant one of both types of healing abutments is placed
* Suturing
* Standardized radiography to measure bone-levels at baseline
* Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
* 2 weeks after Baseline:
o Removal of the sutures
* 4 weeks after Baseline:
* A 2nd digital impression of the soft tissue with an intra-oral scanner
* Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
* Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
* Removal of the Healing Abutment with the attached soft tissue en-bloque.
* Placement of a new, regular, Encode Healing Abutment.
* 10 weeks after Baseline:
* Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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2 types of healing abutment
Patients who are in need of minimal 2 dental implants, who will receive both types of healing abutments.
normal healing abutment
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
nano-structured healing abutment
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
Interventions
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normal healing abutment
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
nano-structured healing abutment
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Periodontally compromised patients
* Patients who took antibiotics 3 months before implantation
* Patients with uncontrolled diabetes
* Pregnant patients
* Patients who received radiotherapy in the head/neck region
* Patients under chemotherapy
* Patients who had intravenous use of bisphosphonates
18 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Hugo De Bruyn, DDS, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University
Ghent, , Belgium
Countries
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Other Identifiers
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2012/341
Identifier Type: -
Identifier Source: org_study_id