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| Name | Class |
|---|---|
| Klockner Implant System | UNKNOWN |
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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.
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
5.3.2. Exclusion criteria
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks, 6 months, 1 and 3 years |
| Peri-implant disease incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javi Vilarrasa | Contact | 628553000 | jvilarrasa@uic.es |
| Name | Affiliation | Role |
|---|---|---|
| Javi Vilarrasa | Universitat Internacional de Catalunya | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40070156 | Derived | 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. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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This is a prospective, randomized, triple blind, controlled clinical trial
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The incidence of peri-implant disease will be assessed at 1 and 3 years attending to the 2017 World Workshop Classification |
| 1 and 3 years |