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The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Implant placement and prosthetic rehabilitation of the missing tooth |
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| SCTG group | Experimental | Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth. |
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| CM group | Experimental | Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth. |
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| PADM group | Experimental | Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Tissue graft augmentation | Procedure | Donor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture |
| Measure | Description | Time Frame |
|---|---|---|
| soft tissue volume gain | Optical scans superposition | after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| soft tissue volume stability | Optical scans superposition | after 15 months |
| Plaque index (PI) | Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972) |
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Inclusion Criteria:
Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andres Pascual La Rocca, DDS | Contact | 0034627725044 | pascuallarocca@hotmail.com | |
| Cristina Valles Vega, DDS | Contact | 0034627725044 | cristinavallveg@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andres Pascual La Rocca, DDS | Universitat Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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controlled randomized prospective clinical study.
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| Implant Placement | Procedure | A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed. |
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| at baseline, after 12 weeks and after 15 months. |
| Bleeding on probing (BI) | Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After a gentle probing if the gingiva bleeds will be positive. | at baseline, after 12 weeks and after 15 months. |
| Probing depth (PD) | in the implant area (implant and both tooth next to it). Distance from the gingival margin to the bottom of the gingival sulcus using periodontal probe (UNC 15). Measured in 6 points: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual. | at baseline, after 12 weeks and after 15 months. |
| Width of keratinized tissue (KT) | in the implant area (implant and both teeth nxt to it). Measured in the medial buccal point of the tooth/implant. Distance from mucogingival junction to the most apical portion of the crest of the marginal gingiva. The mucogingival junction will be identified by the roll technique, wherein the mucosa is rolled until the non-movable portion of the attached keratinized tissue is seen | at baseline, after 12 weeks and after 15 months. |
| Phenotype evaluation (PT) | the gingival biotype was categorized as thin or thick based on the transparency of a periodontal probe (CP15 UNC; Hu-Friedy, Chicago, IL, USA) through the soft tissues while probing the buccal sulcus of the contra-lateral tooth (17-19) | at baseline, after 12 weeks and after 15 months. |
| Patient reported outcome measures (PROMs) | patient pain/discomfort will be evaluated (a questionnaire will be provided to each patient after all the surgery procedures and it will be recollected the day of suture removal) | after the surgery procedures (baseline) and after 7 days (suture removal) |
| Pink Esthetic Score (PES) | will be registered to obtain information related to the papilla, the level of soft-tissue margin, the alveolar process, the color, contour and texture of the same soft tissue | After 2 weeks of the definite crown placement (around 16 months) |