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

Primary Purpose

Peri-Implantitis, Implant Infection, Microbial Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citric acid abutment
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-Implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Citric acid abutment

    Control non coated abutment

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    October 19, 2022
    Last Updated
    October 19, 2022
    Sponsor
    Universitat Internacional de Catalunya
    Collaborators
    Klockner Implant System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05592327
    Brief Title
    Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease
    Official Title
    Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease: a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 3, 2022 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Internacional de Catalunya
    Collaborators
    Klockner Implant System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis, Implant Infection, Microbial Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a prospective, randomized, triple blind, controlled clinical trial
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Citric acid abutment
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control non coated abutment
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Citric acid abutment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Biofilm quantification
    Description
    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
    Time Frame
    12 weeks, 6 months, 1 and 3 years
    Secondary Outcome Measure Information:
    Title
    Protein expression markers
    Description
    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
    Time Frame
    12 weeks, 6 months, 1 and 3 years
    Title
    Peri-implant disease incidence
    Description
    The incidence of peri-implant disease will be assessed at 1 and 3 years attending to the 2017 World Workshop Classification
    Time Frame
    1 and 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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. 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 those that desire to withdraw the study or have any adverse reactions to the materials employed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Javi Vilarrasa
    Phone
    628553000
    Email
    jvilarrasa@uic.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Javi Vilarrasa
    Organizational Affiliation
    Universitat Internacional de Catalunya
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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