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

Centro Specialistico Odontoiatrico, Rome

Status: Enrolling

Conditions: Soft Tissue Augmentation; Bone Augmentation; Dental Implant; Tooth Extraction Status Nos

Treatments: Procedure: Prosthetically driven implant placement

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04367766

IIP/ARP/SH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

Immediate Implant Placement

Active Comparator group

Description:

prosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization.

Treatment:

Procedure: Prosthetically driven implant placement

Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:

Active Comparator group

Description:

ARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \< 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \< 2mm

Treatment:

Procedure: Prosthetically driven implant placement

Spontaneous Healing + Delayed Implant Placement

Active Comparator group

Description:

extraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \< 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \< 2mm .

Treatment:

Procedure: Prosthetically driven implant placement