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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:
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Implant Placement | Active Comparator | 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: | Active Comparator | 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 | Active Comparator | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetically driven implant placement | Procedure | Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome Measurements | Patient's satisfaction with the final result will be assessed by means of a 100 mm VAS scale ranging from 0 (no satisfaction) to 100 (best possible satisfaction), recording patient's experience | crown delivery, 1, 3, 5 years post loading |
| Clinical parameters: Probing Depth (PD) and Recession (REC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Clementini, DDS, PhD | Contact | 00393388378866 | mclementini@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Marco Clementini, DDS, PhD | Centro Specialistico Odontoiatrico, Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Specialistico Odontoiatrico (CSO) | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31215112 | Background | Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131. | |
| 31050359 |
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all IPD that underlie results will be presented in open access publication in international peer-reviewed journal
From the publication acceptance by the international peer-reviewed journal
Open access publication
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|
| 1, 3, 5 years post loading |
Probing Depth (PD) and Recession (REC) will be recorded in mm. with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) |
| crown delivery, 1, 3, 5 years post loading |
| Clinical parameters: Bleeding on Probing (BoP) | Bleeding on Probing (BoP) will be recorded as presence/absence with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) | crown delivery, 1, 3, 5 years post loading |
| Marginal Bone Level (MBL) | Marginal Bone Level (MBL) will be evaluated by a blinded examiner analysing an intra-oral radiograph on a computer software (Image J), as the distance in mm. between the smooth-rough interface and the mesial and distal bone level. The radiographs will be performed using a customized PVS bite block and an alignment device | crown delivery, 1, 3, 5 years post loading |
| Aesthetic | Aesthetic will be evaluated by a blinded examiner analysing pictures using the modified pink and white aesthetic score (PES/WES system, Belser et al. 2009) and giving a score from 0 to 20. | crown delivery, 1, 3, 5 years post loading |
| Volumetric bone and soft tissue changes | Volumetric bone change will be assessed by a blinded examiner analysing on a computer software (SMOP) DICOM files from cone-beam computed tomography (CBCT) scan. Contour soft tissue change and buccal soft tissue volume will be assessed by a blinded examiner analysing on a computer software (SMOP) STL files from digital impression. Dynamic Soft tissue healing will be assessed by a blinded examiner analysing superimposition on a computer software (SMOP) of DICOM files (from CBCT) and STL files (from digital impression) | before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery. |
| Background |
| Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31. |