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Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites.
Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study.
At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed).
After 4 months of healing, patients undergo a radiographic examination before implant placement.
A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces.
Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2).
Follow up is scheduled 1 year after prosthetic loading (T3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARP 50:50 | Tooth extraction + ARP with collagenated porcine bone hand-mixed (ratio 50:50) with a thermogel |
| |
| ARP 80:20 | Tooth extraction + ARP with collagenated porcine bone pre-mixed (ratio 80:20) with a thermogel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tooth extraction with alveolar ridge preservation | Procedure | alveolar ridge preservation performed after tooth extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histomorphometric characteristics of the bone: Newly formed bone (NB) | The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples. | T1= 4 months following tooth extraction + ARP |
| Histomorphometric characteristics of the bone: marrow spaces (MS) | The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples | T1= 4 months following tooth extraction + ARP |
| Histomorphometric characteristics of the bone: residual graft particles (RP) | The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples | T1= 4 months following tooth extraction + ARP |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level | Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact. | T1= 4 months following tooth extraction + ARP |
| Marginal Bone Level |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring hopeless tooth extraction followed by ARP and implant-prosthetic rehabilitation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Odontostomatologia e Chirurgia del Cavo Orale | Pisa | Italy | 56126 | Italy |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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| Implant placement | Procedure | Implant placement |
|
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact. |
| T2= 3 months following implant placement |
| Marginal Bone Level | Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact. | T3= 1-year follow-up |
| Horizontal alveolar measure | Maximum post-extractive buccal/lingual distance (measured in millimeters) of the socket evaluated with a UNC periodontal probe | Day 1 = tooth extraction + ARP |
| Horizontal alveolar measure | Maximum alveolar crest width at implant placement (measured in millimeters) evaluated with a UNC periodontal probe | T1= 4 months following tooth extraction + ARP |
| Vertical alveolar measure | Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe | Day 1 = tooth extraction + ARP |
| Vertical alveolar measure | Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe | T1= 4 months following tooth extraction + ARP |
| Aesthetic outcomes | evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14 | T2= 3 months following implant placement |
| Aesthetic outcomes | evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14 | T3= 1-year follow-up |