Missing Tooth/Teeth
Conditions
Brief summary
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).
Interventions
the test group were placed in an Argon plasma reactor
Sponsors
Paolo Pesce
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* presence of at least 4 mm of keratinized mucosa around the implants * patients aged 18 years or older * medically healthy patients (ASA I), or patients with mild systemic disease (ASA II) * partially edentulous state * healthy periodontal condition (also including periodontal health on reduced periodontium) according to the referent case definition
Exclusion criteria
* ASA physical status 3 * severe smokers (\> 10 cig/day) * patients undergoing bisphosphonate therapy * pregnant or lactating women * estrogen-related hormonal disorders or hormonal substitution therapy * untreated periodontitis (pocket depth 4mm with positive bleeding on probing) * multiple gingival recession * patients with a history of head and neck cancers and radiotherapy in this region.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perimplant tissue inflammation | 3 months after implant insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connective tissue maturation | 3 months after implant insertion | 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. 1. Partial organization: more collagen fibers but still irregularly arranged; thin, wavy fibers; abundant amorphous matrix persists. 2. Intermediate organization: initial fiber parallelism; collagen bundles alternating with matrix; fibers still partially wavy. 3. Well organized: parallel collagen bundles along the epithelial plane; reduced interstitial spaces; reduced amorphous matrix; fewer fibroblasts. 4. Complete maturation: dense, regular collagen bundles; consistent and continuous orientation; dense, stable, poorly cellular connective tissue. |
| Epithelial regeneration | 3 months after implant insertion | Evaluation of thickness, continuity, and maturation of the overlying epithelium. Scores: 0 Epithelium absent or severely discontinuous; ulcerated or completely denuded areas. 1. Partial regeneration: covered zones alternating with denuded or de-epithelialized areas. 2. Almost complete: continuous epithelium but with reduced thickness and/or not fully stratified cellular structure. 3. Complete but thin: stratified epithelium present, with fewer cell layers than normal. 4. Complete, stratified epithelium; well-developed with multiple layers, perfect continuity, and regular morphology. |
Contacts
Primary ContactLuigi Canullo
Outcome results
None listed