Peri-implant Tissue Healing Assessed by Proteomic AnalysisNCT07246499
Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.
A study testing Pink anodized implant abutment. and Grey machined implant abutment. in people with Peri-implant Tissue Healing Assessed by Proteomic Analysis, run by University of Valencia at 1 site in Spain.
Trial summary
The main objective of the study is to perform proteomic adsorption analysis on machined (grey) and anodised (pink) surfaces and compared them. The aim is to evaluate the regenerative potential involving improvement in the healing of peri-implant soft tissues in patients with dental implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Tissue Healing Assessed by Proteomic Analysis
- What is being tested?
- Pink anodized implant abutment. and Grey machined implant abutment.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Number of missing teeth and, therefore, number of implants required.
- A minimum of 4 implants, either single or bridges, must always be used in order to place 2 machined abutments and 2 anodised abutments.
- Sufficient bone dimensions for a minimum implant diameter of 3.5-4 mm and length of 6-8 mm, without prior bone regeneration.
- Patients who require indirect breast lift simultaneously with implant placement may be included in the study.
- Minimum keratinised mucosa dimension of 1.5-2.0 mm in all directions.
- Previous healthy bone condition for 3 months without infection.
- Periodontal health with no history of periodontitis (Silness and Löe plaque index, bleeding on probing (BOP) < 3 mm).
Who cannot join
- Patients unable to complete follow- up.
- Implant failures.
- Contamination of the sample during transfer from the abutment to the test tube.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Transmucosal Abutments for Dental Implants.
The main objective of the study is to perform proteomic adsorption analysis on machined (grey) and anodised (pink) surfaces and compared them. The aim is to evaluate the regenerative potential involving improvement in the healing of peri-implant soft tissues in patients with dental implants. This surgery is indicated in healthy patients when they lost their teeth.
The main question it seeks to answer is:
Read more
- In dental abutments, is anodised surface more effective than machined surface in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two dental abutments applied as part of the standard surgical procedure. Subsequently, participants will undergo clinical and proteomic follow-up assessments to evaluate the progress and extent of peri-implant tissue healing over a three-months period.
- Being tested
- Pink anodized implant abutment., Grey machined implant abutment.
- Keywords
- peri-implant healing, proteomics, tissue regeneration, Evaluation of proteomic outcomes in peri-implant tissue healing., Pink anodized implant abutment, Grey machined implant abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pink anodized implant abutment.Device
Also called Pink anodized dental abutment, Anodized titanium abutment
Participants will receive a pink anodized titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
Grey machined implant abutment.Device
Also called Grey machined dental abutment, Machined titanium abutment
Participants will receive a grey machined titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pink anodized titanium implant abutment. | Experimental | Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis. Receives: Device: Pink anodized implant abutment. |
| Grey machined titanium implant abutment. | Active comparator | Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis. Receives: Device: Grey machined implant abutment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic analysis of peri-implant tissue healing.
Proteomic profiling of peri-implant tissues will be performed to characterise protein expression patterns associated with tissue healing, enabling the identification of molecular markers of tissue regeneration.
Measured: 7 days and 3 months after abutment placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Nov 2025
- Primary completion1 Mar 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Tissue Healing Assessed by Proteomic AnalysisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santiago de Compostela
- Responsible party
- Principal investigator, Juan Carlos Bernabeu Mira, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246499
- Sponsor's protocol ID
- 1. UV-INV_ETICA-3792382
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing of individual participant data is under consideration. Should data be shared in the future, all institutional regulations will be followed to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Transmucosal Abutments for Dental Implants.
- ClinicalTrials.gov ID
- NCT07246499
- Acronym / sponsor ID
- 1. UV-INV_ETICA-3792382
- Keywords
- peri-implant healing, proteomics, tissue regeneration, Evaluation of proteomic outcomes in peri-implant tissue healing., Pink anodized implant abutment, Grey machined implant abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- University of Santiago de Compostela
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 24 Nov 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 main objective of the study is to perform proteomic adsorption analysis on machined (grey) and anodised (pink) surfaces and compared them. The aim is to evaluate the regenerative potential involving improvement in the healing of peri-implant soft tissues in patients with dental implants. This surgery is indicated in healthy patients when they lost their teeth.
The main question it seeks to answer is:
- In dental abutments, is anodised surface more effective than machined surface in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two dental abutments applied as part of the standard surgical procedure. Subsequently, participants will undergo clinical and proteomic follow-up assessments to evaluate the progress and extent of peri-implant tissue healing over a three-months period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pink anodized titanium implant abutment. | Experimental | Device: Pink anodized implant abutment.Participants will receive a pink anodized implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis. |
| Grey machined titanium implant abutment. | Active comparator | Device: Grey machined implant abutment.Participants will receive a grey machined implant abutment, and peri-implant tissue healing will be assessed through proteomic analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Number of missing teeth and, therefore, number of implants required.
- A minimum of 4 implants, either single or bridges, must always be used in order to place 2 machined abutments and 2 anodised abutments.
- Sufficient bone dimensions for a minimum implant diameter of 3.5-4 mm and length of 6-8 mm, without prior bone regeneration.
- Patients who require indirect breast lift simultaneously with implant placement may be included in the study.
- Minimum keratinised mucosa dimension of 1.5-2.0 mm in all directions.
Key exclusion criteria (3 listed)
- Patients unable to complete follow- up.
- Implant failures.
- Contamination of the sample during transfer from the abutment to the test tube.
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 |
|---|---|---|
| Pink anodized implant abutment.Also: Pink anodized dental abutment, Anodized titanium abutmentParticipants will receive a pink anodized titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis. | Device | Pink anodized titanium implant abutment. |
| Grey machined implant abutment.Also: Grey machined dental abutment, Machined titanium abutmentParticipants will receive a grey machined titanium implant abutment placed during the surgical and osseointegrated phase of treatment. Peri-implant tissue healing will be assessed over a three-month follow-up period through clinical examination and proteomic analysis. | Device | Grey machined titanium implant abutment. |
Primary outcome
Proteomic analysis of peri-implant tissue healing.
Time frame: 7 days and 3 months after abutment placement.
Proteomic profiling of peri-implant tissues will be performed to characterise protein expression patterns associated with tissue healing, enabling the identification of molecular markers of tissue regeneration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided. The sharing of individual participant data is under consideration. Should data be shared in the future, all institutional regulations will be followed to protect participant confidentiality.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pink anodized implant abutment. and Grey machined implant abutment. in people with Peri-implant Tissue Healing Assessed by Proteomic Analysis, run by University of Valencia at 1 site in Spain.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic analysis of peri-implant tissue healing. (time frame: 7 days and 3 months after abutment placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.