Peri-ImplantitisNCT05592327
Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease
A study testing Citric acid abutment in people with Peri-Implantitis and Implant Infection, run by Universitat Internacional de Catalunya.
Trial summary
The use of dental implants is a predictable procedure to replace the missing tooth with high rates of success and survival. In addition, placing the abutment on the same day as the implant surgery is a safe and biologically sound procedure to minimize bone loss and peri-implant inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Implant Infection, Microbial Disease
- What is being tested?
- Citric acid abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2022to Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with ≥18 years old.
- Systemically healthy patients.
- Patients with healthy periodontal status with a full mouth plaque index ≤ 20% (O'Leary, 1972) and full mouth bleeding index (Ainamo \& Bay, 1975) before implant surgery.
- Need for at least one dental implant in maxillary and mandibular partially posterior edentulous healed sites.
Who cannot join
- Patients with some special conditions that could interfere surgical oral procedures.
- Patients with non-treated periodontal disease.
- Patients with uncontrolled systemic disease that could impair wound healing (i.e. Diabetes Mellitus).
- Pregnant women.
- Patients allergic to any metallic component of the materials.
- Need for bone or soft tissue reconstruction simultaneous to implant placement.
Show all 9Show fewer
- Lack of primary stability during implant placement (i.e., insertion torque < 25 N, ISQ > 60)
- Smokers ≥ 10 cigarettes per day.
- Patients will be excluded from the study if they violate any of the criteria during the trial, as well as those that desire to withdraw the study or have any adverse reactions to the materials employed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease: a Randomized Controlled Clinical Trial
The use of dental implants is a predictable procedure to replace the missing tooth with high rates of success and survival. In addition, placing the abutment on the same day as the implant surgery is a safe and biologically sound procedure to minimize bone loss and peri-implant inflammation. Although citric acid antibacterial coating has never been tested in vivo, recent in vitro data support its clinical use due to its antibacterial effect at the abutment level.
This prospective randomized controlled clinical trial aims to evaluate the microbiological and inflammatory profile of implant abutments coated with citric acid.
Read the detailed description
The study population will consist on patients referred to the Department of Periodontology at Universitat Internacional de Catalunya for the replacement of missing teeth and who meet the following inclusion criteria will be included consecutively in the study.
5.3.1. Inclusion criteria
- Patients with ≥18 years old.
- Systemically healthy patients.
- Patients with healthy periodontal status with a full mouth plaque index ≤ 20% (O'Leary, 1972) and full mouth bleeding index (Ainamo \& Bay, 1975) before implant surgery.
- Need for at least one dental implant in maxillary and mandibular partially posterior edentulous healed sites.
5.3.2. Exclusion criteria
- Patients with some special conditions that could interfere surgical oral procedures.
- Patients with non-treated periodontal disease.
- Patients with uncontrolled systemic disease that could impair wound healing (i.e. Diabetes Mellitus).
- Pregnant women.
- Patients allergic to any metallic component of the materials.
- Need for bone or soft tissue reconstruction simultaneous to implant placement.
- Lack of primary stability during implant placement (i.e., insertion torque < 25 N, ISQ > 60)
- Smokers ≥ 10 cigarettes per day.
- Patients will be excluded from the study if they violate any of the criteria during the trial, as well as if they desire to withdraw the study or have any adverse reactions to the materials employed.
The primary outcome measure will be the reduction of biofilm formation at the test abutments compared with the control abutments at the 12 weeks 6 months, 1 year and 3 year of follow-up. Biofilm formation over abutments will be quantified with Ilumina sequencing analysis.
- Conditions
- Peri-Implantitis, Implant Infection, Microbial Disease
- Being tested
- Citric acid abutment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric acid abutmentProcedure or surgery
The implant surgery will be performed by 3rd year residents of the Postgraduate Program in Periodontology at UIC, supervised by a board-certified periodontist (J.V). Under local anaesthesia, a mid crestal incision will be performed and a full thickness flap will be raised. Implants will be placed following the manufacturer's recommendations. Implant shoulder (IS) will be placed 1 mm subcrestally, and a distance of ≥ 1.5 mm from adjacent natural tooth and ≥ 3 mm between implants will be always respected. Implant stability will be measured with Ostell ISQ. Straight definitive abutments (2 mm height) will be tightened to 25 N respecting the previous randomization procedure. One of the implants will receive an antibacterial- coated abutment (citric acid), while the other implant will receive a non-coated abutment (C). A protector cap will be screwed manually. Implant sites will be sutured with polypropylene 5/0 (Prolene Ethicon, USA) by simple stitches.
| Study group | Role | What they receive |
|---|---|---|
| Citric acid abutment | Experimental | Antimicrobial-coated abutments (citric acid) will be allocated to the test group.
Permanent Vega® (Klockner Implant System, Barcelona, Spain) will be used. The interface between implant and abutment is platform switching. The abutment height will be of 2 mm. It will be placed the day of the implant surgery and tighten to 25 N Receives: Procedure: Citric acid abutment |
| Control non coated abutment | Placebo comparator | Non- coated abutments (citric acid) will be allocated to the control group. Permanent Vega® (Klockner Implant System, Barcelona, Spain) will be used. The interface between implant and abutment is platform switching. The abutment height will be of 2 mm. It will be placed the day of the implant surgery and tighten to 25 N Receives: Procedure: Citric acid abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm quantification
The primary outcome measure will be the reduction of biofilm formation at the test abutments compared with the control abutments at the 12 weeks, 6 months, 1 year and 3 years. Biofilm formation over the retrieved abutments will be quantified by means of Illumina sequencing analysis
Measured: 12 weeks, 6 months, 1 and 3 years
Secondary outcomes (2)
Protein expression markers
Quantification of protein expressions (IL-10 beta, IL-8 and TNF-beta) for the test and control abutments. This quantification will be performed at 12 weeks, 6 months, 1 and 3 years
Measured: 12 weeks, 6 months, 1 and 3 years
Peri-implant disease incidence
The incidence of peri-implant disease will be assessed at 1 and 3 years attending to the 2017 World Workshop Classification
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start3 Nov 2022 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 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 Peri-ImplantitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, triple blind, controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Responsible party
- Principal investigator, Javi Vilarrasa, Universitat Internacional de Catalunya
- Investigators
- Javi Vilarrasa, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592327
- Sponsor's protocol ID
- PER-ECL-2021-04
- Status last verified
- Oct 2022
- First submitted
- 19 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vilarrasa J, Pereira Couto C, Alvarez G, Carrio N, Gil J, Blanc V, Nart J. Microbiological, Inflammatory and Clinical Outcome of Citric Acid Passivated Definitive Abutments: Interim 12-Month Results From a Randomised Controlled Clinical Trial. J Clin Periodontol. 2025 Jun;52(6):813-825. doi: 10.1111/jcpe.14146. Epub 2025 Mar 11.
PubMed 40070156
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05592327
- Acronym / sponsor ID
- PER-ECL-2021-04
- Conditions
- Peri-Implantitis, Implant Infection, Microbial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Study start
- 3 Nov 2022 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Oct 2022 (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 use of dental implants is a predictable procedure to replace the missing tooth with high rates of success and survival. In addition, placing the abutment on the same day as the implant surgery is a safe and biologically sound procedure to minimize bone loss and peri-implant inflammation. Although citric acid antibacterial coating has never been tested in vivo, recent in vitro data support its clinical use due to its antibacterial effect at the abutment level.
This prospective randomized controlled clinical trial aims to evaluate the microbiological and inflammatory profile of implant abutments coated with citric acid.
Detailed description
The study population will consist on patients referred to the Department of Periodontology at Universitat Internacional de Catalunya for the replacement of missing teeth and who meet the following inclusion criteria will be included consecutively in the study.
5.3.1. Inclusion criteria
- Patients with ≥18 years old.
- Systemically healthy patients.
- Patients with healthy periodontal status with a full mouth plaque index ≤ 20% (O'Leary, 1972) and full mouth bleeding index (Ainamo \& Bay, 1975) before implant surgery.
- Need for at least one dental implant in maxillary and mandibular partially posterior edentulous healed sites.
5.3.2. Exclusion criteria
- Patients with some special conditions that could interfere surgical oral procedures.
- Patients with non-treated periodontal disease.
- Patients with uncontrolled systemic disease that could impair wound healing (i.e. Diabetes Mellitus).
- Pregnant women.
- Patients allergic to any metallic component of the materials.
- Need for bone or soft tissue reconstruction simultaneous to implant placement.
- Lack of primary stability during implant placement (i.e., insertion torque < 25 N, ISQ > 60)
- Smokers ≥ 10 cigarettes per day.
- Patients will be excluded from the study if they violate any of the criteria during the trial, as well as if they desire to withdraw the study or have any adverse reactions to the materials employed.
The primary outcome measure will be the reduction of biofilm formation at the test abutments compared with the control abutments at the 12 weeks 6 months, 1 year and 3 year of follow-up. Biofilm formation over abutments will be quantified with Ilumina sequencing analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, triple blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Citric acid abutment | Experimental | Procedure: Citric acid abutmentAntimicrobial-coated abutments (citric acid) will be allocated to the test group. Permanent Vega® (Klockner Implant System, Barcelona, Spain) will be used. The interface between implant and abutment is platform switching. The abutment height will be of 2 mm. It will be placed the day of the implant surgery and tighten to 25 N |
| Control non coated abutment | Placebo comparator | Procedure: Citric acid abutmentNon- coated abutments (citric acid) will be allocated to the control group. Permanent Vega® (Klockner Implant System, Barcelona, Spain) will be used. The interface between implant and abutment is platform switching. The abutment height will be of 2 mm. It will be placed the day of the implant surgery and tighten to 25 N |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ≥18 years old.
- Systemically healthy patients.
- Patients with healthy periodontal status with a full mouth plaque index ≤ 20% (O'Leary, 1972) and full mouth bleeding index (Ainamo \& Bay, 1975) before implant surgery.
- Need for at least one dental implant in maxillary and mandibular partially posterior edentulous healed sites.
Key exclusion criteria (9 listed)
- Patients with some special conditions that could interfere surgical oral procedures.
- Patients with non-treated periodontal disease.
- Patients with uncontrolled systemic disease that could impair wound healing (i.e. Diabetes Mellitus).
- Pregnant women.
- Patients allergic to any metallic component of the materials.
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 |
|---|---|---|
| Citric acid abutmentThe implant surgery will be performed by 3rd year residents of the Postgraduate Program in Periodontology at UIC, supervised by a board-certified periodontist (J.V). Under local anaesthesia, a mid crestal incision will be performed and a full thickness flap will be raised. Implants will be placed following the manufacturer's recommendations. Implant shoulder (IS) will be placed 1 mm subcrestally, and a distance of ≥ 1.5 mm from adjacent natural tooth and ≥ 3 mm between implants will be always respected. Implant stability will be measured with Ostell ISQ. Straight definitive abutments (2 mm height) will be tightened to 25 N respecting the previous randomization procedure. One of the implants will receive an antibacterial- coated abutment (citric acid), while the other implant will receive a non-coated abutment (C). A protector cap will be screwed manually. Implant sites will be sutured with polypropylene 5/0 (Prolene Ethicon, USA) by simple stitches. | Procedure or surgery | Citric acid abutment, Control non coated abutment |
Primary outcome
Biofilm quantification
Time frame: 12 weeks, 6 months, 1 and 3 years
The primary outcome measure will be the reduction of biofilm formation at the test abutments compared with the control abutments at the 12 weeks, 6 months, 1 year and 3 years. Biofilm formation over the retrieved abutments will be quantified by means of Illumina sequencing analysis
2 secondary outcomes
Protein expression markers
Time frame: 12 weeks, 6 months, 1 and 3 years
Peri-implant disease incidence
Time frame: 1 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 40070156Vilarrasa J, Pereira Couto C, Alvarez G, Carrio N, Gil J, Blanc V, Nart J. Microbiological, Inflammatory and Clinical Outcome of Citric Acid Passivated Definitive Abutments: Interim 12-Month Results From a Randomised Controlled Clinical Trial. J Clin Periodontol. 2025 Jun;52(6):813-825. doi: 10.1111/jcpe.14146. Epub 2025 Mar 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Javi Vilarrasa principal investigator
Universitat Internacional de Catalunya
Questions about this trial
What is this clinical trial studying?
A study testing Citric acid abutment in people with Peri-Implantitis and Implant Infection, run by Universitat Internacional de Catalunya.
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 9 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javi Vilarrasa (628553000, jvilarrasa@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm quantification (time frame: 12 weeks, 6 months, 1 and 3 years). 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 NCT05592327, 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 Oct 2022.