Tooth Fractures
Conditions
Interventions
This is a prospective, standardized, case series pilot study. Twelve individuals aged 22 to 75 years old, who require removal of a single-root tooth and qualify for immediate implant placement without
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
iDentical Inc
Eligibility
Age
22 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 22 to 75 years; Indication for the extraction of a single-rooted tooth with immediate implant placement for a single-unit prosthetic restoration; Adequate bone height and width with intact cortical plates (> 1 mm in thickness) at the surgical site for implant placement; Satisfactory soft tissue quality, quantity, and morphology; Ability to fully comprehend and provide informed consent; willingness and ability to adhere to study procedures and instruction
Exclusion criteria
Exclusion criteria: General contraindications for dental and/or surgical treatments; Presence of apical lesions or peri-radicular bone loss; Untreated periodontitis, peri-implantitis, or other uncontrolled oral infections; Inadequate oral hygiene (plaque score > 25% or bleeding on probing > 50% of sites); Bruxing or clenching habits; Cuspid protected occlusion; Presence of diabetes, cancer, HIV infection, or bone metabolic diseases; Concurrent or recent use of immunosuppressants, systemic corticosteroids, intramuscular or intravenous bisphosphonates within two months prior to the study; Undergoing or having undergone radiation therapy and/or chemotherapy; Current smokers or individuals who had not quit smoking for at least two years; Pregnant or lactating women, and women of childbearing age intending to become pregnant during the study; Individuals requiring replacement of additional teeth during the study period or with ongoing implant treatments; or participants in other studies clinical studies involving therapeutic intervention (medical or dental); Additional exclusion criteria specific to the time of tooth extraction and implant insertion: Exclusion criteria at time of extraction: Insufficient or fractured bone at the extraction site (buccal plate < 1 mm thick or fenestrations); Fractured, chipped, or distorted tooth root pos-extraction; Significant defect in the extraction socket with one or more missing bone walls; Active infection present in the extraction socket; Communication between the extraction socket and sinus, inferior alveolar nerve canal or mental foramina; Tooth root not compatible with the dimensions of the intended implant device; Exclusion criteria at time of implant insertion: Presence of infection, pain, bleeding, or significant tissue swelling or trauma before implant placement; Change in medical or dental history that related to the exclusion criteria before tooth extraction; Failure to place the implant within 14 days of the extraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A success rate (osseointegration) of at least 95% is expected to be found clinically and radiographically after 12 months of placing the custom implants, verified through clinical and radiographic evaluation. Absence of peri-implant radiolucency, mobility (Miller index), suppuration, pain (visual analogue scale), and marginal bone loss (less than 1.7 mm) will be observed | — |
Secondary
| Measure | Time frame |
|---|---|
| A low incidence of adverse events such as infections, fractures, loss of adjacent teeth, and other technical and/or biological problems is expected to be found. All adverse events that may occur during the 12 months after implant placement will be monitored and documented. Good peri-implant tissue acceptance is expected to be observed, evidenced by a keratinized tissue width greater than 2mm on all implant faces after 6 months of implant placement surgery. Patients are expected to report a high level of satisfaction with the esthetics of the treatment, verified by the Visual Analogue Scale of satisfaction (VAS), with an average score of at least 8 on a scale from 0 to 10. The evaluation will be done after placing the prostheses on the implants, at 6 and 12 months. An improvement in chewing capacity is expected to be observed, assessed through a patient-reported outcomes (PROs) questionnaire, with an increase of at least 20% in the score. The questionnaire will be applied before tooth extraction and after 12 months of implant placement | — |
Countries
Brazil
Contacts
Public ContactMarilia Gomes
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed