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Recent data suggested that an adequate volume of Keratinized Tissue (KT) around dental implant is a key factor to obtain aesthetic outcomes and to support easy long-term maintenance.
The aim of this RCT is to test the volume-stable collagen matrix (VCMX) vs the Connective Tissue Graft (CTG) for peri-implant soft tissue augmentation during implant uncovering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCMX | Experimental | All patients will be treated by scaling/root planing to obtain infection control if needed. In addition, patients will receive oral hygiene instructions. The test group will be treated with add of VCMX. Following the local anesthesia, a split thickness flap will be raised-up to uncover the implant screw. Care will be taken to preserve pre-existing KT amount. A mesio-distal and apical partial thickness dissection will be performed to release residual muscle tension and allow the passive apical displacement of the flap. The randomisation envelope will be then opened. In test group the VCMX will be gently shaped and secured under the flap with suture. Care will be applied to completely cover the xenograft. |
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| CTG | Active Comparator | The control group patients will be treated by flap surgery with add of CTG. In the control group (APF) a CTG harvested from palate will be secured under the flap with suture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCMX | Device | A flap will be raised and VCMX will be placed in order to increase the soft tissue volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | Immediately After Surgery |
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | 1 week After surgery |
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | 2 weeks After surgery |
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | 4 weeks After surgery |
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | 3 months After surgery |
| GT | Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. | 6 months after surgery |
| GT |
| Measure | Description | Time Frame |
|---|---|---|
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100)) | Immediately After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli Studi di Firenze | Florence | FI | 50134 | Italy |
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Examiners will be blinded throughout all experimental procedures for all measurements.
Operators will be blinded until they will raise the flap and screw the healing abutment.
| CTG | Procedure | A flap will be raised and a CTG will be harvested from the palate and placed in order to increase the soft tissue volume |
|
Changes in the gingival thickness (in mm) measured 1.0 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface. |
| 12 months after surgery |
| PROMs |
After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) |
| 1 week After surgery |
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) | 2 weeks After surgery |
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) | 4 weeks After surgery |
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) | 3 months After surgery |
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) | 6 months after surgery |
| PROMs | After explanation of the post-operative instructions patients will be given an evaluation questionnaire. Patient discomfort during procedure (from 0 to 10) and the overall judgment about the self-perception of procedure difficulty will be assed using a Visual Analogue Scale (VAS- (from 0 to 100) | 12 months after surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | At Baseline |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 1 week After surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 2 weeks After surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 4 weeks After surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 3 months After surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 6 months after surgery |
| KT | The distance between muco-gingival junction, in mm, (MGJ) to the most coronal point of the ridge using a periodontal probe | 12 months after surgery |