Clinical trial NCT05592327: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Implant Infection
Microbial Disease
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Klockner Implant System
First posted: 2022-10-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, triple blind, controlled clinical trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Biofilm quantification
timeFrame: 12 weeks, 6 months, 1 and 3 years
Secondary outcomes:
measure: Protein expression markers
timeFrame: 12 weeks, 6 months, 1 and 3 years
measure: Peri-implant disease incidence
timeFrame: 1 and 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Javi Vilarrasa
role: PRINCIPAL_INVESTIGATOR
References: