Trials / Not Yet Recruiting
Not Yet RecruitingNCT06614426
Surgical Treatment of Peri-implantitis Defects
The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin (L-PRF) in the Surgical Treatment of Peri-implantitis Defects: a Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- Sponsor
- Abeer Hakam · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Test group 1 (T1) | Test group 1 (T1): Open flap debridement using electrolysis decontamination |
| PROCEDURE | Test group 2 (T2) | Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application |
| PROCEDURE | Control group (C) | Conventional open flap debridement |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2026-11-30
- Completion
- 2026-12-30
- First posted
- 2024-09-26
- Last updated
- 2024-09-26
Source: ClinicalTrials.gov record NCT06614426. Inclusion in this directory is not an endorsement.