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The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.
Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.
Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Will receive standard healing abutments |
|
| Individualized healing abutment group | Experimental | Will receive individualized healing abutments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard healing abutment | Device | Participants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Buccal-lingual/palatal soft tissue dimensional changes | They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dehiscence of peri-implant vestibular and lingual/palatal mucosa: | Dehiscence can be assessed by carefully examining the peri- implant mucosa for any signs of tissue separation or exposure. This can be done visually during clinical examination. | 12 months |
| Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javi Vilarrasa, MSc | Contact | +34 628553000 | jvilarrasa@uic.es | |
| Nicolas Padros, DDs | Contact | +34 628289185 | nico.padros@uic.es |
| Name | Affiliation | Role |
|---|---|---|
| Matteo Albertini, PhD | Universidad Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Recruiting | Barcelona | Catalonia | 08195 | Spain |
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Randomized clinical trial
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| Individualized healing abutment | Device | Participants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment |
|
To measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions. measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions. |
| 12 months |
| Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT) | CBCT scans can also be used to assess horizontal remodeling of the cortical bone. Analyze the CBCT images to measure changes in cortical thickness or contour. | 12 months |
| Thickness of vestibular and lingual/palatal cortex (CBCT) | CBCT scans can provide measurements of cortical thickness in the vestibular and lingual/palatal regions of the alveolar bone. | 12 months |
| Vertical changes of the vestibular and lingual/palatine cortex (CBCT) | Use CBCT scans to measure any vertical changes in the vestibular and lingual/palatal cortical bone regions. | 12 months |
| Marginal bone level (periapical x-ray) | Periapical X-rays are commonly used to assess marginal bone levels around dental implants. Measure the distance from the implant-abutment interface to the crestal bone on these radiographs. | 12 months |
| Probing pocket depth | Probing pocket depth can be measured using periodontal probes. Insert the probe gently into the peri-implant sulcus and measure the distance from the mucosal margin to the implant-abutment interface. | 12 months |
| Bleeding/Suppuration on probing | Assess bleeding or suppuration during probing. Note if there is any bleeding or exudate from the peri-implant sulcus when probing the tissues. | 12 months |
| Implant survival | Implant survival can be determined by assessing whether the implant remains in place and functional over the study period. Any implant removals or failures should be documented. | 12 months |
| Patient-reported variables (satisfaction, pain) | Subjective assessment of pain intensity and patient satisfaction using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain and discomfort (i.e., no pain and the worst imaginable pain)
| 12 months |