Management of the Fresh Extraction Socket in the Aesthetic Area

Study Overview
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Brief Summary
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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: Immediate Implant Placement and Immediate Provisionalization Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed. 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
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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.

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

Conditions
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Tooth Extraction Status Nos, Dental Implant, Bone Augmentation, Soft Tissue Augmentation

Intervention / Treatment
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* Procedure: Prosthetically driven implant placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Implant Placement<br>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. | Procedure: Prosthetically driven implant placement<br>* Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan<br>* Other names: Prosthetically driven implant installation;|
| Active Comparator: Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:<br>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 | Procedure: Prosthetically driven implant placement<br>* Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan<br>* Other names: Prosthetically driven implant installation;|
| Active Comparator: Spontaneous Healing + Delayed Implant Placement<br>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 . | Procedure: Prosthetically driven implant placement<br>* Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan<br>* Other names: Prosthetically driven implant installation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adjunctive bone and soft tissue augmentation procedures need. | 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. | during implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-Implant Health | 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 | 1, 3, 5 years post loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate implant placement, alveolar ridge preservation, delayed implant placement, PROMs, implant health, volumetric analysis, tissue augmentation