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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade do Porto
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- D- Bleeding on probing (clinical variables)
Study Overview
Brief 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.
Detailed Description
The study is a prospective randomized clinical trial performed by a single investigator, without a control group. The project was designed in 2016 and the participants were recruited between 2017 and 2021.
Patients who met the inclusion criteria were recruited by the Unit of Oral Surgery and Implantology of the University of Porto from 2017 to 2021. The patients were fully informed of the characteristics of the study and were invited to participate. A complete medical history was taken for each of the patients, and they also underwent a thorough oral examination. The investigation was carried out in accordance with the criteria recommended in the CONSORT Guidelines.
- Sample characterization The sample will consist of clinical cases of unitary tooth loss in the region of incisors, canines, and maxillary premolars of patients from the clinic of the Faculty of Dental Medicine of the University of Porto. The study follows ethical principles of the Ethics Committee of the Faculty of Dental Medicine, University of Porto, and guidelines from the Declaration of Helsinki for clinical trials with humans.
Thus, after informed consent, the patients will be randomly grouped into 2 groups, through a closed letter draw:
Group I- patients submitted to the protocol of immediate placement of the V3 Mis® implant; Group II- patients submitted to the protocol of immediate placement of C1 MIS® implant. 2. Surgical protocol
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The envelopes were prepared prior to the start of the clinical study, mixed and stored. before each surgery, an envelope was randomly taken for the preparation of the surgery
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged 18 and over
- •Patients with understanding and free decision-making for informed consent
- •Patients who need rehabilitation of a tooth in the region of incisors, canines, or maxillary premolars
- •Patients with EDS-1 or EDS-2 dental sockets, according to Caplanis N. classification.
Exclusion Criteria
- •Patients with systemic pathologies that contraindicate the surgical procedure;
- •Prolonged Non-steroidal anti-inflammatory drugs (NSAIDs);
- •Bisphosphonate therapy;
- •Lack of opposing teeth on implant site;
- •Lack of adjacent teeth on implant site;
- •Dental-sockets with total loss of one of the cortical;
- •Untreated periodontal pathology;
- •Pathology or circumstance that prevents patients from attending routine check-ups;
- •Patients who smoke more than 10 cigarettes/day. Smokers are advised to reduce or stop smoking.
Outcomes
Primary Outcomes
D- Bleeding on probing (clinical variables)
Time Frame: 6 months
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.
F- Implant insertion torque (Clinical variables)
Time Frame: T1
Recording of implant insertion torque, in Ncm during placement in T1, and compare implants results.
G- Implant stabilization quotient (ISQ) (clinical variables)
Time Frame: 6 months
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.
B- Bacterial plaque index (O'Leary index)(clinical variables)
Time Frame: 6 months
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.
A - Bone defect (clinical variables)
Time Frame: T0
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.
C- Probing depth (clinical variables)
Time Frame: 6 months
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.
E- Gingival phenotype (clinical variables)
Time Frame: T-1
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.
Imaging periapical X-ray evaluation (millimeter)
Time Frame: 6 months
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.
Morphometric evaluation (clinical direct measurements)
Time Frame: 6 months
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.
Morphometric evaluation (plaster models measurements)
Time Frame: 6 months
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.
PES/WES index - Photography results
Time Frame: 6 months
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.
Cone Beam Tomography (CBCT) evaluation (millimeter)
Time Frame: 6 months
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.
Secondary Outcomes
- Biological complication(6 months)
- Prosthetic complication(6 months)
- Osseointegration survival rate(6 months)