The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.
Research design * Prospective, in which participants will be recruited and then followed up throughout a specified period of time. * Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups. * Single-blinded as the outcome accessors will be blinded to the intervention. Materials and Methods: Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria: Inclusion criteria: * Aged 18 or over. * Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling). * Screw retained implant crown. * Good compliance and commitment to attend follow-up review appointments. * Willing to provide informed consent. Exclusion criteria * History of surgical therapy of peri-implantitis. * Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect). * Cement retained implant crown. * Systemic/local antibiotics during the previous 6 months. * Bone metabolic disease and/or taking medications that affect bone metabolism. * History of malignancy, radiotherapy or chemotherapy. * Pregnant or lactating women. * Smokers The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study. Randomization, allocation concealment and blinding: The participants will be randomly allocated to three equally sized groups using computer-generated numbers: Control group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Test group 1 (T1): Open flap debridement using electrolysis decontamination
Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application
Conventional open flap debridement
Probing pocket depth
\- Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Presence or absence of plaque, bleeding on probing and suppuration
Presence or absence of plaque, bleeding on probing and suppuration: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe
Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Peri-implant marginal bone level
\- Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs.
Time frame: Baseline (prior to surgical intervention), 12 and 24 months
Peri-implant soft tissue level
\- Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Peri-implant soft tissue thickness (Phenotype)
\- Peri-implant soft tissue thickness (Phenotype): measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using an endodontic spreader at 3 points.
Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
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