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The goal of this clinical trial is to evaluate the effect of abutment surface bioactivation via argon plasma treatment on peri-implant soft tissue healing and integration in adult patients undergoing implant therapy.
The main questions it aims to answer are:
Does argon plasma treatment of healing abutments improve the quality and organization of peri-implant connective tissue compared to untreated abutments?
Does the treatment influence histological parameters such as epithelial regeneration, vascularization, inflammatory infiltrate, and keratin layer thickness?
Researchers will compare plasma-treated healing abutments to untreated machined-surface abutments to determine whether the bioactivated surface improves soft tissue morphogenesis.
Participants will:
Undergo implant placement with immediate connection of either a treated or untreated healing abutment.
Have plaque and bleeding indices recorded at 3 months.
Undergo a soft tissue biopsy at 3 months for histological analysis (including evaluation of inflammation, connective tissue, epithelial morphology, vascularization, and keratinization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated abutments | Experimental | abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation |
|
| Non treated abutment | No Intervention | Abutment without any surface treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the test group were placed in an Argon plasma reactor | Device | the test group were placed in an Argon plasma reactor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perimplant tissue inflammation | Evaluation of density and distribution of inflammatory cells (lymphocytes, plasma cells, granulocytes, macrophages) in the peri-epithelial connective tissue will be evaluated and a score will be used; 0 Massive infiltrate, diffusely present throughout the section; dense cellular aggregates; severely disturbed connective architecture. 1. Intense infiltrate, present in most of the section but not fully diffuse; clearly visible focal aggregates. 2 Moderate infiltrate, 3 Minimal infiltrate; isolated low-density cellular foci; connective tissue mostly unaffected. 4 No recognizable inflammatory infiltrate; only resident normal cells present. | 3 months after implant insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Connective tissue maturation | Organization and maturation of collagen fibers in the subepithelial connective tissue. Score: 0 Immature, disorganized tissue; sparse, wavy, randomly oriented collagen fibers; abundant amorphous matrix; numerous active fibroblasts.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Canullo | Contact | +393476201976‬ | luigicanullo@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37853303 | Result | Canullo L, Donato A, Savadori P, Radovanovic S, Iacono R, Rakic M. Effect of argon plasma abutment activation on soft tissue healing: RCT with histological assessment. Clin Implant Dent Relat Res. 2024 Feb;26(1):226-236. doi: 10.1111/cid.13286. Epub 2023 Oct 18. |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| 3 months after implant insertion |
| Epithelial regeneration | Evaluation of thickness, continuity, and maturation of the overlying epithelium. Scores: 0 Epithelium absent or severely discontinuous; ulcerated or completely denuded areas.
| 3 months after implant insertion |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |