Abutment Hydrophilicity on Soft Tissue Morphogenesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: the test group were placed in an Argon plasma reactor.
- Who it may be relevant to
- Registry conditions: Missing Tooth/Teeth. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT
Overview
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
- Device the test group were placed in an Argon plasma reactor
the test group were placed in an Argon plasma reactor
Primary outcome measures
- Perimplant tissue inflammation [Time frame: 3 months after implant insertion]
Secondary outcome measures (2)
- Connective tissue maturation [Time frame: 3 months after implant insertion]
- Epithelial regeneration [Time frame: 3 months after implant insertion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 37853303
Identifiers
NCT: NCT07082088 · hydrophilicity