One-abutment One-time for Immediate Restoration Procedure in the Esthetic Zone
- Conditions
- Implant Tissue Failure
- Interventions
- Procedure: guided surgeryProcedure: conventionnel implant placement
- Registration Number
- NCT04139512
- Lead Sponsor
- University of Liege
- Brief Summary
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
- Detailed Description
Objectives: The aim of this randomized control trial was to compare immediate restoration procedure with a one abutment one-time technique using a conventional versus full digital workflow. Surgical accuracy, provisional fit and patient reported outcome measures (PROMs) of.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description guided surgery guided surgery test group, using a full digital workflow procedure conventional technic conventionnel implant placement free- hand technic to place implant
- Primary Outcome Measures
Name Time Method Assessment of the surgical accuracy The day of the surgery The STL files (stereolithography files) were superimposed with pre-operative CBCT (Cone beam computed tomography) images using automated surface best fit matching with the iterative closest point algorithm in the treatment evaluation mode, coDiagnostiX® software version 9.7 (Dental Wings Inc). The mean deviations at the implant shoulder and apex between the planned and actual implant positions were measured in millimeters (mm), as well as the divergence of the implant axis in degrees. All measurements were performed by a single dentist, who conducted the virtual implant planning in all cases.
Clinical fit of the provisional restoration measurements 10 days post surgery The measurements were based on the adaptation of the provisional crown. Interproximal contacts were evaluated according to the criteria described by Syrek (Syrek et al., 2010). Dental floss (Johnson \& Johnson Reach®, Waxed dentotape, New Brunswick, NJ, USA) was used to check the interproximal contact. A score from 1 to 4 was given to the fitting criteria (the higher the score, the better the adaptation).
- Secondary Outcome Measures
Name Time Method WES 10 days post surgery To evaluate the esthetic outcomes of the provisional crown, the White Esthetic Score (WES) was reported. The highest WES score was 10, which represented a close match with the clinical single-tooth crown present at the contralateral natural tooth or neighboring teeth. The WES was evaluated by a blinded prosthodontic, based on photography.
Patient-reported outcomes measures (PROMs) 10 days post surgery PROMs were obtained using a VAS form immediately after the immediate restoration of the implant. Five questions were used:
1. Do you feel your provisional tooth as a natural tooth? (0 = not at all to 10, absolutely).
2. Do you find your provisional tooth looks like a natural tooth? (0 = not at all to 10, absolutely).
3. How much discomfort did you feel during the physical impression? (0 = little or 10, a lot) for the control group.
How much discomfort did you feel during the optical impression? (0 = little to 10, a lot) for the test group.
4. Would you be willing to undergo this treatment again? (0= not at all to 10, absolutely).
5. Are you satisfied with the aesthetics outcomes of your provisional tooth. (0 = not at all to 10, absolutely).
Trial Locations
- Locations (1)
CHU de Liège - Service de Médecine Dentaire
🇧🇪Liège, Belgium