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

NCT05592327 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-10-24

No results posted yet for this study

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

Interventions

PROCEDURE

Citric acid abutment

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.

Sponsors & Collaborators

  • Klockner Implant System

    collaborator UNKNOWN

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Javi Vilarrasa · Universitat Internacional de Catalunya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2025-10-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592327 on ClinicalTrials.gov