Management of the Fresh Extraction Socket in the Aesthetic Area

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04367766
Study type	Interventional
Source	Centro Specialistico Odontoiatrico, Rome
Contact	Marco Clementini, DDS, PhD
Phone	00393388378866
Email	mclementini@me.com
Status	Recruiting
Phase	N/A
Start date	September 27, 2023
Completion date	August 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Management of the Fresh Extraction Socket in the Aesthetic Area — IIP/ARP/SH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms