Effect of Bio-activation on Epithelial and Connective Cell Adhesion to Titanium Abutments: Split Mouth Clinical Trial
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: No limits · 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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Overview
The aim of this "in vivo" controlled trial is to assess soft tissue cell adhesion to titanium abutments subjected to different cleaning procedures - no treatment (as they come from the industry), and cleaning by plasma- at an early healing time. In fact, the primary aim is Quantity and Quality of soft tissue adhesion at the microscopic level (e.g Fibronectin, Integrin-actin). The secondary Aim - Clinical parameters and outcomes - BOP, PPD, MBL (Marginal Bone Level to check influence of plasmapp-treated abutments). The null hypothesis of the study was that the cleaning procedure applied to implant abutments has no effect on soft tissue cell adhesion and MBL at an early healing time.
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
- connective tissue coverage [Time frame: 3 months post-op]
Secondary outcome measures (2)
- Connective tissue density [Time frame: 3 months post-op]
- Mean bon loss [Time frame: 1 year post-op]
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)
- Total or partial edentulous state with space for at least 2 implants
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 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
- Crossover
- 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: NCT07069231 · Abutment adhesion