NCT04367766

Management of the Fresh Extraction Socket in the Aesthetic Area

Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centro Specialistico Odontoiatrico, Rome · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Tooth Extraction Status Nos
• Dental Implant
• Bone Augmentation
• Soft Tissue Augmentation

Interventions

Type	Name	Description
PROCEDURE	Prosthetically driven implant placement	Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan

Timeline

• Start date: 2023-09-27
• Primary completion: 2024-04-01
• Completion: 2026-08-01
• First posted: 2020-04-29
• Last updated: 2023-12-12

Locations

1 site across 1 country: Italy