Surgical Treatment of Peri-implantitis Defects
- Conditions
- Peri Implantitis
- Interventions
- Procedure: Control group (C)Procedure: Test group 1 (T1)Procedure: Test group 2 (T2)
- Registration Number
- NCT06614426
- Lead Sponsor
- Abeer Hakam
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 57
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (C): Conventional open flap debridement Control group (C) Conventional open flap debridement Test group 1 (T1): Open flap debridement using electrolysis decontamination Test group 1 (T1) Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF Test group 2 (T2) Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application
- Primary Outcome Measures
Name Time Method Probing pocket depth Baseline (prior to surgical intervention), 3, 6, 12 and 24 months - Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
- Secondary Outcome Measures
Name Time Method Presence or absence of plaque, bleeding on probing and suppuration Baseline (prior to surgical intervention), 3, 6, 12 and 24 months 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
Peri-implant marginal bone level Baseline (prior to surgical intervention), 12 and 24 months - Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs.
Peri-implant soft tissue level Baseline (prior to surgical intervention), 3, 6, 12 and 24 months - Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
Peri-implant soft tissue thickness (Phenotype) Baseline (prior to surgical intervention), 3, 6, 12 and 24 months - 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.