Missing Tooth/TeethNCT07069231
Effect of Bio-activation on Epithelial and Connective Cell Adhesion to Titanium Abutments: Split Mouth Clinical Trial
A study testing the test group were placed in an Argon plasma reactor in people with Missing Tooth/Teeth, run by Universita degli Studi di Genova.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, 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)
- Total or partial edentulous state with space for at least 2 implants
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 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
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.
- 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 |
|---|---|---|
| Machined Abutment - control | No intervention | The control group received MUA without plasma treatment. |
| Plasma abutment - test | Experimental | .The MUA allocated to the test group will be placed in a plasma reactor (Plasmapp, South Korea) for decontamination and activation of the surface. In order to restrict any post-treatment contamination; abutments will be inserted immediately after the end of the plasma process. Receives: Device: the test group were placed in an Argon plasma reactor |
What is being measured
The primary outcome is the main question the study is designed to answer.
connective tissue coverage
- Coverage was defined as the extent to which the abutment surface was occupied by adherent cells. It reflects the spatial distribution of cells across the surface, providing a measure of surface colonization.
Coverage was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.
Measured: 3 months post-op
Secondary outcomes (2)
Connective tissue density
- Density was defined as the degree of cellular accumulation in the regions where cells were present. This parameter reflects the local compactness of cells, irrespective of how widely they are spread across the surface.
Density was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.
Measured: 3 months post-op
Mean bon loss
MBL will be measured at 1-year follow up using orthopanoramic or endo-oral Xray.
Measured: 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pesce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069231
- Sponsor's protocol ID
- Abutment adhesion
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bio-activation on Epithelial and Connective Cell Adhesion to Titanium Abutments: Split Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07069231
- Acronym / sponsor ID
- Abutment adhesion
- Conditions
- Missing Tooth/Teeth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 16 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Machined Abutment - control | No intervention | –The control group received MUA without plasma treatment. |
| Plasma abutment - test | Experimental | Device: the test group were placed in an Argon plasma reactor.The MUA allocated to the test group will be placed in a plasma reactor (Plasmapp, South Korea) for decontamination and activation of the surface. In order to restrict any post-treatment contamination; abutments will be inserted immediately after the end of the plasma process. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 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)
- Total or partial edentulous state with space for at least 2 implants
Key exclusion criteria (5 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 patients with a history of head and neck cancers and radiotherapy in this region
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 | Plasma abutment - test |
Primary outcome
connective tissue coverage
Time frame: 3 months post-op
• Coverage was defined as the extent to which the abutment surface was occupied by adherent cells. It reflects the spatial distribution of cells across the surface, providing a measure of surface colonization. Coverage was independently scored on a scale from 1 to 10 by two blinded operators who were unaware of the sample group assignments (i.e., activated vs control). The individual scores were subsequently averaged to obtain a representative value for each parameter per sample.
2 secondary outcomes
Connective tissue density
Time frame: 3 months post-op
Mean bon loss
Time frame: 1 year post-op
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 16 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 Universita degli Studi di Genova.
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 4 inclusion and 5 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 16 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 (+39393476201976, luigicanullo@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
connective tissue coverage (time frame: 3 months post-op). 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 NCT07069231, 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 16 Jul 2025.