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Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.
Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.
The following groups will be randomly assigned:
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.
The primary objective is:
- The implant success
The Secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | A customized PEEK abutment mimicking the subgingival emergence of the extraction site will be screw-retained on the implant to seal the extraction site and to support healing of buccal soft tissues. |
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| Control group | Active Comparator | A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate post-extractive Implant placement | Device | Teeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant success | Evaluated according to the criteria of Albrektsson et al. (1986):
| 1 year of follow up |
| Peri-implant marginal bone level- Radiographic Measurements | Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment. | 1 year of follow up |
| Peri-implant marginal bone level- Radiographic Measurements | Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment. | 2 years of follow up |
| Peri-implant marginal bone level- Radiographic Measurements | Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment. | 3 years of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mid-facial mucosal recession | The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements. |
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Inclusion Criteria:•
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUG | Geneva | 1205 | Switzerland |
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Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.
Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.
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The participants ant the biostatician will be blinded on the assignment group
|
| Implant success | Evaluated according to the criteria of Albrektsson et al. (1986):
| 2 years of follow up |
| Implant success | Evaluated according to the criteria of Albrektsson et al. (1986):
| 3 years of follow up |
| 1 year of follow up |
| Changes in mid-facial mucosal recession | The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements. | 2 years of follow up |
| Changes in mid-facial mucosal recession | The height of the mid-facial mucosa will be measured using the drilling template at baseline before tooth extraction after implant placement at day 45±5 (wound healing day 160±5 (primary endpoint - impression for final restoration) and at 1, 2, 3 years of follow up. Changes of mid-facial mucosal recession will be drawn by subtracting the post-op measurements from the baseline measurements. | 3 years of follow up |
| Changes in papilla height | Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement. | 1 year of follow up |
| Changes in papilla height | Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement. | 2 years of follow up |
| Changes in papilla height | Height of the mesial and distal papilla will be assessed by measuring the distance between the incisal edge and the tip of the papilla using a caliper to the nearest 0.5mm before tooth extraction, after implant placement 45±5 during wound healing and at the time of final impression at 90±5 days, at 160±14 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. Papilla height changes will be assessed by subtracting post-op measurements from baseline measurements before tooth extraction or after implant placement. | 3 years of follow up |
| Changes in soft tissue ridge width - Volumetric measurements | Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 1 year of follow up |
| Changes in soft tissue ridge width - Volumetric measurements | Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 2 years of follow up |
| Changes in soft tissue ridge width - Volumetric measurements | Digital scans of the implant region will be obtained at baseline before tooth extraction and after implant placement, at day 45±5 during wound healing of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 3 years of follow up |
| Aesthetic evaluation (PES) | Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment. | 1 year of follow up |
| Aesthetic evaluation (PES) | Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment. | 2 years of follow up |
| Aesthetic evaluation (PES) | Pink esthetic score will be assessed on photographic images the tooth after final restoration and the insertion of the definitive crown. The assessment will be performed by an independent evaluator unaware of the assigned treatment. | 3 years of follow up |
| Implant stability (ISQ) | Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 90 days after insertion of the definitive crown |
| Implant stability (ISQ) | Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 160 days after insertion of the definitive crown |
| Implant stability (ISQ) | Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 1 year of followup |
| Implant stability (ISQ) | Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 2 years of follow up |
| Implant stability (ISQ) | Implant stability will be assessed using a resonance frequency measurement device and assessing Implant Stability Quotient (ISQ) scores after implant placement, at the time of final impression at 90 days, at 160 days after insertion of the definitive crown and at 1, 2, 3 years of follow up. | 3 years of follow up |