Abutment Hydrophilicity on Soft Tissue Morphogenesis
40 participantsStarted 2025-07-31
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.