Surgical Treatment of Peri-implantitis Defects

Abeer Hakam

Status: Not yet enrolling

Conditions: Peri Implantitis

Treatments: Procedure: Test group 2 (T2); Procedure: Control group (C); Procedure: Test group 1 (T1)

Study type: Interventional

Funder types: Other

Identifiers

NCT06614426

MBRU IRB-2024-563

Details and patient eligibility

About

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.

Full 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

Enrollment: 57 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

57 participants in 3 patient groups

Control group (C): Conventional open flap debridement

Active Comparator group

Description:

Conventional open flap debridement

Treatment:

Procedure: Control group (C)

Test group 1 (T1): Open flap debridement using electrolysis decontamination

Experimental group

Description:

Open flap debridement using (GalvoSurge® - Straumann)

Treatment:

Procedure: Test group 1 (T1)

Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF

Experimental group

Description:

Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application

Treatment:

Procedure: Test group 2 (T2)