Missing Tooth/TeethNCT07082088
Abutment Hydrophilicity on Soft Tissue Morphogenesis
A study testing the test group were placed in an Argon plasma reactor in people with Missing Tooth/Teeth, run by Paolo Pesce.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Tooth/Teeth
- What is being tested?
- the test group were placed in an Argon plasma reactor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT
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:
Read more
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).
- Conditions
- Missing Tooth/Teeth
- Being tested
- the test group were placed in an Argon plasma reactor
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the test group were placed in an Argon plasma reactorDevice
the test group were placed in an Argon plasma reactor
| Study group | Role | What they receive |
|---|---|---|
| Treated abutments | Experimental | abutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation Receives: Device: the test group were placed in an Argon plasma reactor |
| Non treated abutment | No intervention | Abutment without any surface treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 3 months after implant insertion
Secondary outcomes (2)
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.
- Partial organization: more collagen fibers but still irregularly arranged; thin, wavy fibers; abundant amorphous matrix persists.
- Intermediate organization: initial fiber parallelism; collagen bundles alternating with matrix; fibers still partially wavy.
- Well organized: parallel collagen bundles along the epithelial plane; reduced interstitial spaces; reduced amorphous matrix; fewer fibroblasts.
- Complete maturation: dense, regular collagen bundles; consistent and continuous orientation; dense, stable, poorly cellular connective tissue.
Measured: 3 months after implant insertion
Epithelial regeneration
Evaluation of thickness, continuity, and maturation of the overlying epithelium.
Scores:
0 Epithelium absent or severely discontinuous; ulcerated or completely denuded areas.
- Partial regeneration: covered zones alternating with denuded or de-epithelialized areas.
- Almost complete: continuous epithelium but with reduced thickness and/or not fully stratified cellular structure.
- Complete but thin: stratified epithelium present, with fewer cell layers than normal.
- Complete, stratified epithelium; well-developed with multiple layers, perfect continuity, and regular morphology.
Measured: 3 months after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Missing Tooth/TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Pesce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Pesce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082088
- Sponsor's protocol ID
- hydrophilicity
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37853303
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abutment Hydrophilicity on Soft Tissue Morphogenesis: Histological CCT
- ClinicalTrials.gov ID
- NCT07082088
- Acronym / sponsor ID
- hydrophilicity
- Conditions
- Missing Tooth/Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Paolo PesceUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated abutments | Experimental | Device: the test group were placed in an Argon plasma reactorabutment allocated to the test group were placed in an Argon plasma reactor (Plasmapp, South Korea) for decontamination and activation |
| Non treated abutment | No intervention | –Abutment without any surface treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the test group were placed in an Argon plasma reactorthe test group were placed in an Argon plasma reactor | Device | Treated abutments |
Primary outcome
Perimplant tissue inflammation
Time frame: 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.
2 secondary outcomes
Connective tissue maturation
Time frame: 3 months after implant insertion
Epithelial regeneration
Time frame: 3 months after implant insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Results publication: PubMed 37853303Canullo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing the test group were placed in an Argon plasma reactor in people with Missing Tooth/Teeth, run by Paolo Pesce.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Canullo (+393476201976, luigicanullo@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perimplant tissue inflammation (time frame: 3 months after implant insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07082088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.