At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Morphometric, Imaging and Photographic Comparison of Peri-implant Tissues Between V3 and C1 Mis ® Implants in Post-extraction Alveolus in the Anterior Region of the Maxilla
In Brief
A clinical study evaluating A - Bone defect (clinical variables), B- Bacterial plaque index (O'Leary index)(clinical variables), and 10 other interventions for Dental Implants, Single-Tooth. Completed, enrolled 20 participants across 1 site.
Detailed Summary
One of the challenges of current implantology involves the preservation or reduction of existing bone resorption, mainly in the buccal bone plate, after tooth loss, which becomes of special importance in the anterior region of the maxilla (aesthetic region). The study evaluates the macroscopic shape of neck implant influence in the results of immediate implants, in a population comprised of individuals from the clinic of the Faculty of Dental Medicine of the University of Porto in need of replacement of a single tooth. It is intended to evaluate the morphometric (direct measures and plaster models measurements), imaging, and photographic characteristics of the V3 implant in comparison with the C1 implant of Mis® by an evaluation period of 6 months when placing an immediate implant.
Study Details
Timeline
Interventions
At T0, the edentulous space to be rehabilitated will be characterized in terms of the morphometric level of the existing defect in the vestibular cortical, according to the classification by Caplanis N. in EDS-1 or EDS-2.
At time T-1 and T4, the investigator will analyse the existing plaque on teeth adjacent to the surgical site using a dichotomous score (0 = no visible plaque at the soft tissue margin, 1 = visible plaque at the soft tissue margin). The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4, and compare the results between implants type.
At Time T-1 and T4, the investigators will analyse the probing depth of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in millimeters. The change between T-1 and T4 is also going to be analysed and compare implants results.
At time T-1 and T4, the investigators will analyse the bleeding on probing of the teeth adjacent to the site to be treated at 6 points: mesiobuccal, vestibular, distobuccal, mesiopalatal, palatine, distopalatal. The recordings of bleeding on probing will be carried out with a CP 15 UNC, Hu-Friedy® Chicago, IL, EUA manual probe.The result will be present in percentage (0% (better)-100%(worse)) and will describe the change between T-1 and T4 and compare between implants type.
At time T-1, the identification of the gingival phenotype is performed by clinical inspection with a periodontal probe. The gingival phenotype will be classified as thin, moderate or thick. The investigators will compare implant results.
Recording of implant insertion torque, in Ncm during placement in T1, and compare implants results.
Determination of the implant stability coefficient at the time of implant placement (T1) and in the 2nd surgical phase (T3) using the Osstell® device (minimum 1; maximum 100; high stability when ≥70) and analysis of the change between T1 and T3 and different implants results.
Compare Direct measurements (millimeters) at the different times intervention with periodontal probe or gauge and analyse the change between times and compare implant results. In T-1, T2 and T3c and T4 the investigators will evaluate interdental distance; BPD, cortical bone, papilla and volume, corresponding of measurements: a,b,c and r. In T0, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume corresponding to measurements: a, b, c, d, e, q, r, s, t, and u). In T1 e T3, the investigators will evaluate interdental distance; BPD, cortical, bone and global volume, implant parameter corresponding to measurements: a, b, d, e, f, g, h, I, j, k, l, m, n, p, q, r and ISQ value.
Preparation of plaster models at times T-1 and T4 and the following measurements (millimeter) will be evaluated with the use of periodontal probe or gauge and will analyse the change between T-1 and T4 and compare implants results: 1. interdental distance 2. bucco-palatal distance (BPD) 3. presence of papilla r. global volume.
The investigator will measure (millimeters, using the imaging software virtual ruler) the results of digital X-ray at times T-1, T1,T4 and analyse the variation and compare implants results. The measurements are: a. interdental distance; i. implant - cemento-enamel junction (CEJ) of adject teeth distance; l. distance from the implant position depth to the buccal bone crest; n. implant diameter; o. implant length.
The investigator will measure (millimeters, using the imaging software virtual ruler) the results of CBCT at times T-1 and T4, analyse the variation and compare implants results. The measurements are: 1. interdental distance; 2. bucco-palatal distance (BPD); d. buccal cortical distance; e. palatal cortical distance; f. mesial cortical distance; g. distal cortical distance; h. jumping distance; j. buccal cortical wall-implant distance; k. jumping distance space depth; l. distance from the implant position depth to the buccal bone crest; m. distance from the buccal cortex to the center of the implant; n. implant diameter; o. Implant length; q. global bone volume; r. global volume; s. alveolus buccal-palatal distance; t. alveolus mesial-distal distance; u. alveolus depth.
The investigator will analyse the intraoral photographs to describe the Pes/Wes index, in time T-1 (initial) and T4 (final), and compare the PES/WES results between implants.The score will range on 0-10, the best score is ≥8.