Clinical trial NCT06614426: Surgical Treatment of Peri-implantitis Defects
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri Implantitis
Lead sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Probing pocket depth
timeFrame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Secondary outcomes:
measure: Presence or absence of plaque, bleeding on probing and suppuration
timeFrame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
measure: Peri-implant marginal bone level
timeFrame: Baseline (prior to surgical intervention), 12 and 24 months
measure: Peri-implant soft tissue level
timeFrame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
measure: Peri-implant soft tissue thickness (Phenotype)
timeFrame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861.