Evaluating custom-made dental implants placed immediately after tooth extraction with delayed prosthetic restoration: a pilot study

Not Applicable

• Conditions: Cracked Tooth Syndrome; Tooth Fractures; Tooth, Nonvital; C07.793

• Registration Number: RBR-848ygb3
• Lead Sponsor: Faculdade de Odontologia da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-20
• Last Update Posted: 13 November 2023
• Study Completion: 2023-12-17

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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