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

NCT05899933 | Recruiting

• 1 other identifier: PERIO1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis; Peri-Implant Health

Keywords

Peri-Implantitis; Surgical therapy; Implantoplasty; Air-abrasive device; Erythritol powder; Peri-Implant microbiota

Outcome Measures

Primary Outcomes (4)

• Treatment success as described by the composite outcome of probing pocket depth (PPD) ≤5 mm, absence of bleeding on probing (BoP) and/or suppuration and bone loss ≤0.5 mm between week 2 and 12 months post-surgery, at 12-month examination post-surgery

  The percentage of treatment success will be calculated from the total amount of treated implants. * PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. * BoP will be assessed dichotomously (1=presence, 0=absence) within 30 seconds after probing at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. * Mean change in mm in mean marginal bone level (mesial and distal) will be assessed using an image-processing software. Standardized intra-oral radiographs will be obtained at each time point using a reproducible technique. Marginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact.

  12 months post-surgery

• Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to Week 6 after non-surgical therapy

  Mean total CFU counts from Baseline to Week 6 after non-surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline and at Week 6 after completion of non-surgical therapy. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

  Baseline, Week 6 after non-surgical therapy

• Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to 12 months after surgical therapy

  Mean total CFU counts from Baseline to 12 months after surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline, 3 months post-surgery, 6 months post-surgery and 12 months post-surgery. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

  Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

• Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants of the control group from Baseline to 12 months follow-up visit

  Mean total CFU counts from Baseline to 12 months after Baseline examination will be assessed. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the implant site with the easiest access for sampling at Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.

  Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit

Secondary Outcomes (35)

• Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy

  Baseline, Week 6 after non-surgical therapy

• Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy

  Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

• Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy

  Baseline, Week 6 after non-surgical therapy

• Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy

  Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery

• Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy

  Baseline, Week 6 after non-surgical therapy

Study Arms (3)

Implantoplasty group

EXPERIMENTAL

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.

Procedure: Non-surgical peri-implant therapy; Procedure: Implantoplasty; Procedure: Prophylaxis

Erythritol Air-abrasive device group

EXPERIMENTAL

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.

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

Control group

OTHER

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

Procedure: Prophylaxis

Interventions

Erythritol Air-abrasive device PROCEDURE

Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed. Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implant surface decontamination with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS) will be applied followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.

Erythritol Air-abrasive device group

Implantoplasty PROCEDURE

Screw-retained supraconstructions and, when possible, cement-retained restorations will be removed. Following local anesthesia, intrasulcular incisions will be performed and full-thickness flaps will be elevated on the buccal and lingual aspects of affected implants. Granulation tissue will be removed, and titanium-coated curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy) and NiTi brushes (NEGRIN IN DENTAL) will be applied to remove hard deposits on implants. Osseous recontouring will be performed when indicated followed by irrigations with saline. Implantoplasty will be applied using tungsten carbide burs of various shapes and sizes (Peri-implantitis Kit; Meisinger) followed by irrigations with saline. Flaps will be readjusted and closed with sutures in order to allow a non-submerged healing. Supraconstructions will be reconnected after the surgery.

Implantoplasty group

Non-surgical peri-implant therapy PROCEDURE

2 weeks after baseline examination, non surgical therapy will be applied in implants diagnosed with peri-implantitis prior to enrollment in surgical therapy. Firstly, participants will be instructed in oral hygiene. Professional supragingival and subgingival debridement of implants/ teeth, including the selected for the study implants, will be performed. Local anesthesia will be performed, when needed. Targeted implants will be treated with PEEK-coating ultrasonic tips (Instrument PI; EMS), titanium curettes (IMPM11/12T, IMPM13/14T; Hu-Friedy), rubber cup and polishing paste. Possible adjustments to implant-borne prostheses will be considered, whenever possible. Re-evaluation of non-surgical therapy will be performed after 6 weeks. At the 6-week reevaluation, participants with peri-implant probing pocket depth ≥5 mm and bleeding on probing and/or suppuration in patients with full mouth plaque score ≤20% will proceed to surgical therapy.

Erythritol Air-abrasive device group; Implantoplasty group

Prophylaxis PROCEDURE

Supramucosal biofilm removal of implants/ teeth will be performed at, 3, 6, 9 and 12 months after surgical therapy for the Implantoplasty group and the Erythritol Air-abrasive device group and at 2 weeks, 3, 6, 9 and 12 months after baseline examination for the control group. Targeted implants will be treated with an air-abrasive device (AIRFLOW® MAX, AIRFLOW® Prophylaxis Master; EMS) with erythritol powder (AIRFLOW® Plus Powder; EMS). During these appointments, patients will be re-motivated and re-instructed to oral-hygiene measures.

Control group; Erythritol Air-abrasive device group; Implantoplasty group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens

Athens, 11527, Greece

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Phoebus N. Madianos

  National and Kapodistrian University of Athens

  STUDY CHAIR

Central Study Contacts

Yiorgos A. Bobetsis, Assistant Professor

CONTACT

(+30) 210-746-1097; ybobetsi@dent.uoa.gr

Sotiria Tsantila

CONTACT

soteriatsantila@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The experimental protocol is designed as a double-blind, randomized clinical trial with a 12-month duration and a parallel design

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests will be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified investigators whose proposed research has received Institutional Review Board (IRB) approval. Data will be available via a data repository following execution of data use agreement.

Locations

GR (1)