Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Peri-Implant Health; Peri-Implantitis

Treatments: Procedure: Implantoplasty; Procedure: Non-surgical peri-implant therapy; Procedure: Erythritol Air-abrasive device; Procedure: Prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT05899933

PERIO1

Details and patient eligibility

About

The purpose of the present study is to compare the 1-year clinical, radiographic and microbiological outcomes and patients' satisfaction following surgical treatment of peri-implantitis after applying two different surface modification methods. Secondarily, analysis and comparison of the microbiological results of implants diagnosed and treated for peri-implantitis with healthy implants will be performed.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

General Inclusion Criteria:

• Participants ≥ 18 years and ≤ 80 years of age
• Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago
• Implants in function for more than 1 year after suprastructure connection

Inclusion Criteria for implants diagnosed with Peri-Implantitis:

• Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling

• Absence of implant mobility

  • in participants with more than one implant, the implant with the worst clinical condition will be studied.

Inclusion Criteria for implants diagnosed with Peri-Implant Health:

• Absence of peri-implant signs of inflammation (redness, swelling)
• Lack of bleeding on probing
• Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm

Exclusion criteria

• Smokers
• Uncontrolled diabetes mellitus (HBA1c >7)
• Treatment with bisphosphonates
• Needing antibiotic prophylaxis
• Currently pregnant or breast-feeding women
• History of systemic administration of antibiotic treatment during the preceding 3 months
• Systemic conditions that contraindicate treatment
• Use of medications known to induce gingival hyperplasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Implantoplasty group

Experimental group

Description:

6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.

Treatment:

Procedure: Prophylaxis

Procedure: Non-surgical peri-implant therapy

Procedure: Implantoplasty

Erythritol Air-abrasive device group

Experimental group

Description:

6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.

Treatment:

Procedure: Prophylaxis

Procedure: Erythritol Air-abrasive device

Procedure: Non-surgical peri-implant therapy

Control group

Other group

Description:

Participants with healthy implants will be the comparator group for the microbiological analysis.

Treatment:

Procedure: Prophylaxis