Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease

NCT05592327 | Unknown

• 1 other identifier: PER-ECL-2021-04
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Peri-Implantitis; Implant Infection; Microbial Disease

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks, 6 months, 1 and 3 years

Secondary Outcomes (2)

• Protein expression markers

  12 weeks, 6 months, 1 and 3 years

• Peri-implant disease incidence

  1 and 3 years

Study Arms (2)

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

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

Procedure: Citric acid abutment

Interventions

Citric acid abutment PROCEDURE

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.

Citric acid abutment; Control non coated abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 those that desire to withdraw the study or have any adverse reactions to the materials employed.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Klockner Implant System: collaborator

Related Publications (1)

• 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.

  PMID: 40070156 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Javi Vilarrasa

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javi Vilarrasa

CONTACT

628553000; jvilarrasa@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This is a prospective, randomized, triple blind, controlled clinical trial

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: November 3, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share