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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Peri-Implantitis Implant Infection Microbial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, randomized, triple blind, controlled clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Citric acid abutment

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

Group Type EXPERIMENTAL

Citric acid abutment

Intervention Type 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.

Control non coated abutment

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

Group Type PLACEBO_COMPARATOR

Citric acid abutment

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes