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

Peri-Implantitis Clinical Trial

Official title:

Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05592327
• Other study ID #: PER-ECL-2021-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Universitat Internacional de Catalunya
• Contact: Javi Vilarrasa
• Phone: 628553000
• Email: jvilarrasa[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Implant Infection
• Microbial Disease
• Peri-Implantitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Klockner Implant System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	1 and 3 years