One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone
NCT ID: NCT04139512
Last Updated: 2019-10-25
Study Results
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Basic Information
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COMPLETED
PHASE4
18 participants
INTERVENTIONAL
2018-06-01
2019-08-01
Brief Summary
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Detailed Description
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Material and method: Sites with single edentulous spaces and neighboring natural teeth were randomized into static computer-aided implant surgery (s-CAIS) or freehand placement implant surgery groups. In both groups, digital implant planning was performed using data from cone beam computed tomography (CBCT) and surfaces scans. In the s-CAIS group, a surgical guide was produced and used for fully guided implant surgery, while in the freehand group, the implants were placed in a freehand manner. the deviations in angles, shoulders and apexes between planned and actual implant positions were measured based on postoperative optic impressions. In the test group, a custom-made zirconia abutment and a provisional restoration were immediately placed using a full digital workflow whereas in the control group, a physical impression was taken, and the abutment and crown were placed 10 days post-surgery. Loading outcomes (interproximal contact, occlusal contact, white esthetic score (WES)) were assessed as the PROMs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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guided surgery
test group, using a full digital workflow procedure
guided surgery
placement of implant with local anesthesia using full guided surgery protocol versus free- hande one
conventional technic
free- hand technic to place implant
conventionnel implant placement
placement of dental implant with conventionnal freehand technic
Interventions
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guided surgery
placement of implant with local anesthesia using full guided surgery protocol versus free- hande one
conventionnel implant placement
placement of dental implant with conventionnal freehand technic
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years old
* Single missing tooth or 2 non-adjacent missing teeth in the aesthetic area of the upper jaw. Patients who require an extraction and immediate implant placement can be included.
* Men/women
* Good systemic health (ASA I/II)
* No contra indication against oral surgical interventions
* At least 10 mm in the vertical dimension
* At least 7 mm in the bucco-palatal dimension
* No need for simultaneous bone augmentation procedure. However, a bone augmentation could have been realized 4 months prior to the digital planning of the surgery
* Healthy periodontal condition and full mouth plaque score (FMPS) lower or equal than 25%
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) Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection will undergo a medical treatment prior to its entrance to the study.
In case of systemic infection, the evaluation will be based on medical anamneses and, if necessary, will be referred to relevant medical tests.
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers, more than 10 cigarettes per day
* Untreated local inflammation
* Mucosal disease or oral lesions
* History of local irradiation therapy in the head-neck area
* Persistent intraoral infection
* Patients with bad oral hygiene or unmotivated for normal home care
18 Years
ALL
Yes
Sponsors
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University of Liege
OTHER
Responsible Party
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Dr. France LAMBERT
Professor , doctor
Locations
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CHU de Liège - Service de Médecine Dentaire
Liège, , Belgium
Countries
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Other Identifiers
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B707201731117
Identifier Type: -
Identifier Source: org_study_id
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