None listed
Conditions
Brief summary
1) This study will enroll 40 adults with active peri-implantitis, defined by bone loss and deep gum pockets. 2) All participants will undergo standard ultrasonic implant cleaning. Group A (control) will receive a saline rinse, while Group B (test) will have 24% EDTA gel (PrefGel) applied to the implant for four minutes after the debridement. 3) The study will be blinded. Researchers assessing outcomes will not know group assignments to ensure unbiased data collection. 4) After 3 and 6 months the condition of the implant and surrounding gums will be evaluated for inflammation and bleeding. This will determine whether PrefGel is effective in managing peri-implantitis.
Interventions
All treatments will be performed under local anaesthesia at the target implant. In both groups, mechanical debridement of the target implant and immediately adjacent sites will be carried out using Cavitron ultrasonic machine operated at low power (power 1) with 100% irrigation for 5 minutes. In the test group, ultrasonic debridement will be performed for 5 minutes, after which a 24% neutral pH EDTA gel (PrefGel, Straumann, Switzerland) will be applied into the peri-implant pocket and around exp
All treatments will be performed under local anaesthesia at the target implant. In both groups, mechanical debridement of the target implant and immediately adjacent sites will be carried out using Cavitron ultrasonic machine operated at low power (power 1) with 100% irrigation for 5 minutes. In the test group, ultrasonic debridement will be performed for 5 minutes, after which a 24% neutral pH EDTA gel (PrefGel, Straumann, Switzerland) will be applied into the peri-implant pocket and around exposed implant threads using a syringe with a blunt cannula. The gel will be left in situ for 4 minutes without further mechanical instrumentation to allow adequate contact time. This will be followed by thorough irrigation with sterile saline for 2 minutes to remove residual gel. All the treatments willl be perfromed by an experiience periodontist. All the recording of the clinical parameters from baseline to the 3rd and 6th month reviews will be performed by an experienced Oral Health Therapist who is blinded on the treatment groups of the patients.
Sponsors
Otago University - Faculty of Dentistry
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Adults equal to or greater 20 years with at least one osseointegrated implant in function for at least 12 months will be screened. 2) The target implant must meet predefined peri-implantitis criteria at screening, namely probing pocket depth (PPD) equal to or greater than 6 mm at at least 1 site, the presence of bleeding on probing (BoP) and/or suppuration on probing (SoP), and radiographic bone loss equal to or greater than 2 mm from the expected crestal level or equal to or greater than 3 threads apical to the most coronal bone–implant contact (when thread pitch is known), assessed on a standardized periapical radiograph. 3) In addition, patients must present with a full-mouth plaque score equal to or less than 20% at baseline or after a brief hygiene optimization visit, and must be able to provide written informed consent and comply with study procedures.
Exclusion criteria
1) Systemic conditions known to compromise wound healing (e.g., uncontrolled diabetes mellitus with HbA1c >55 mmol/mol, immunosuppression, ongoing chemotherapy or radiotherapy), 2) Current or previous intravenous bisphosphonate or denosumab therapy, 3) Pregnancy or lactation, 4) Known allergy or hypersensitivity to EDTA or any study material 5) Recent antimicrobial exposure (systemic antibiotics within the preceding 3 months or antiseptic mouthrinse with chlorhexidine or essential oils within 2 weeks, unless a standardized washout can be achieved). 6) Patients who have undergone periodontal surgery or implant surface decontamination at the target implant within the last 6 months 7) Heavy smokers (>10 cigarettes/day or equivalent nicotine vaping) 8) Individuals with untreated rampant caries or unstable periodontitis requiring urgent intervention 9) Implants exhibiting mobility, 10) Implants in clearly non-optimal position or with clearly inadequate restorations that cannot be corrected before inclusion will also be excluded. 11) Light smokers will be allowed but will be accounted for in the analysis.
Outcome results
None listed