Peri-Implantitis Clinical Trial
Official title:
Citric Acid Passivation on Implant Abutments for the Prevention of Peri-implant Disease: a Randomized Controlled Clinical Trial
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitat Internacional de Catalunya | Klockner Implant System |
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 |
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