Abutment Hydrophilicity on Soft Tissue Morphogenesis
ConditionMissing Tooth/Teeth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPaolo Pesce
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
ASA physical status 3
severe smokers (> 10 cig/day)
patients undergoing bisphosphonate therapy
pregnant or lactating women
Trial design
Design model
Parallel
Treatments tested in this trial
the test group were placed in an Argon plasma reactor
Devicethe test group were placed in an Argon plasma reactor
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Treated abutmentsExperimental treatment 1 intervention
Group B: Non treated abutmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months after implant insertionSecondary outcomes
1
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. 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.
Time frame
3 months after implant insertion2
Epithelial regeneration
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.
Time frame
3 months after implant insertionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Paolo Pesce
Lead sponsor
Universita degli Studi di Genova
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: