Management of the Fresh Extraction Socket in the Aesthetic Area
- Conditions
- Dental ImplantBone AugmentationSoft Tissue AugmentationTooth Extraction Status Nos
- Interventions
- Procedure: Prosthetically driven implant placement
- Registration Number
- NCT04367766
- Lead Sponsor
- Centro Specialistico Odontoiatrico, Rome
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- growing patients
- patients with autoimmune disease, uncontrolled diabetes or immunocompromised
- history of head and neck radiation for cancer treatment,
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Implant Placement Prosthetically driven implant placement 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. Alveolar Ridge Preservation (ARP) + Delayed Implant Placement: Prosthetically driven implant placement 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 Spontaneous Healing + Delayed Implant Placement Prosthetically driven implant placement 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 .
- Primary Outcome Measures
Name Time Method Rate of adjunctive bone and soft tissue augmentation procedures need. during implant placement Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness \< 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.
- Secondary Outcome Measures
Name Time Method Peri-Implant Health 1, 3, 5 years post loading Peri-implant health will be assessed as a frequency (Yes/No) at 1, 3, 5 years after prosthetic crown delivery by a blinded examiner in case of: absence of clinical signs of inflammation, absence of bleeding and/or suppuration on gentle probing, no increase in probing depth compared to previous examinations, absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling
Trial Locations
- Locations (1)
Centro Specialistico Odontoiatrico (CSO)
🇮🇹Roma, Italy