Bone Augmentation, Dental Implant, Soft Tissue Augmentation, Tooth Extraction Status Nos
Conditions
Keywords
Immediate implant placement, alveolar ridge preservation, delayed implant placement, PROMs, implant health, volumetric analysis, tissue augmentation
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.
Interventions
PROCEDUREProsthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Sponsors
Centro Specialistico Odontoiatrico, Rome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical parameters: Bleeding on Probing (BoP) | crown delivery, 1, 3, 5 years post loading | 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) |
| Marginal Bone Level (MBL) | crown delivery, 1, 3, 5 years post loading | 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 |
| Patient Reported Outcome Measurements | crown delivery, 1, 3, 5 years post loading | 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 |
| Volumetric bone and soft tissue changes | before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery. | 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) |
| Aesthetic | crown delivery, 1, 3, 5 years post loading | 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. |
| Clinical parameters: Probing Depth (PD) and Recession (REC) | crown delivery, 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) |
Countries
Italy
Contacts
Primary ContactMarco Clementini, DDS, PhD
Outcome results
None listed