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Management of the Fresh Extraction Socket in the Aesthetic Area

Management of the Fresh Extraction Socket in the Aesthetic Area

Recruiting
18 years and older
All
Phase N/A

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Overview

After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:

  1. Immediate Implant Placement and Immediate Provisionalization
  2. Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
  3. Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.

In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.

Description

The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:

  • patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
  • cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
  • volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
  • clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
  • Implant Success and Survival at 1, 3 and 5 years after final prosthesis.

Eligibility

Inclusion Criteria:

  • single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
  • smoking no more than 10 cigarettes/day,
  • periodontal health (BoP < 10%) and good plaque control (< 20%)
  • absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
  • extraction sites with less than 30% loss of one or more walls
  • adequate quantity and quality of native bone to achieve primary stability

Exclusion Criteria:

  • growing patients
  • patients with autoimmune disease, uncontrolled diabetes or immunocompromised
  • history of head and neck radiation for cancer treatment,
  • pregnancy

Study details
    Tooth Extraction Status Nos
    Dental Implant
    Bone Augmentation
    Soft Tissue Augmentation

NCT04367766

Centro Specialistico Odontoiatrico, Rome

27 January 2024

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