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AzTrials

Peri-ImplantitisNCT05899933

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

A study testing Non-surgical peri-implant therapy, Implantoplasty and Erythritol Air-abrasive device in people with Peri-Implantitis and Peri-Implant Health, run by National and Kapodistrian University of Athens at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Peri-Implantitis, Peri-Implant Health
What is being tested?
Non-surgical peri-implant therapy, Implantoplasty and Erythritol Air-abrasive device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGreece
Study dates
28 Jul 2023to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yiorgos A. Bobetsis, Assistant Professor contact

(+30) 210-746-1097

ybobetsi@dent.uoa.gr

Sotiria Tsantila contact

soteriatsantila@gmail.com

Greece1 site, 1 recruiting

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

    Athens, 11527

    Yiorgos A. Bobetsis, 210-746-1097 ext. +30, ybobetsi@dent.uoa.gr

    Sotiria Tsantila, 6975661234 ext. +30, soteriatsantila@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Implantoplasty Versus Implant Decontamination With Erythritol Air-abrasive Device During Surgical Therapy of Peri-implantitis. Clinical, Radiographic and Microbiological Evaluation. A Randomized Controlled Clinical Study

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.

Being tested
Non-surgical peri-implant therapy, Implantoplasty, Erythritol Air-abrasive device, Prophylaxis
Keywords
Peri-Implantitis, Surgical therapy, Implantoplasty, Air-abrasive device, Erythritol powder, Peri-Implant microbiota
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-surgical peri-implant therapyProcedure or surgery

    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.

  • ImplantoplastyProcedure or surgery

    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.

  • Erythritol Air-abrasive deviceProcedure or surgery

    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.

  • ProphylaxisProcedure or surgery

    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.

Study groups in NCT05899933
Study groupRoleWhat they receive
Implantoplasty groupExperimental6 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.
Receives: Procedure: Non-surgical peri-implant therapy; Procedure: Implantoplasty; Procedure: Prophylaxis
Erythritol Air-abrasive device groupExperimental6 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.
Receives: Procedure: Non-surgical peri-implant therapy; Procedure: Erythritol Air-abrasive device; Procedure: Prophylaxis
Control groupOtherParticipants with healthy implants will be the comparator group for the microbiological analysis.
Receives: Procedure: Prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-surgery

  2. 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.

    Measured: Baseline, Week 6 after non-surgical therapy

  3. 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.

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

  4. 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.

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

Secondary outcomes (35)

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

    Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and Week 6 after non-surgical therapy.

    At each examination, PPD will be recorded at six sites per targeted implant. 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

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

    Mean peri-implant probing pocket depth (PPD) will be assessed at Baseline examination and 12 months after surgical therapy.

    At each examination, PPD will be recorded at six sites per targeted implant. 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 studied implant.

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

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

    Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline examination and Week 6 after non-surgical therapy.

    At each examination, PPD will be recorded at six sites per targeted implant. 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

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

    Mean change in mm in peri-implant probing pocket depth (PPD) will be assessed between Baseline and 12 months after completion of surgical therapy.

    PPD will be recorded at six sites per targeted implant. 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 studied implant.

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

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

    Bleeding on probing will be assessed dichotomously as present (1 for bleeding presence) or absent (0 for bleeding absence) within 30 seconds after probing.

    BoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

    Measured: Baseline, Week 6 after non-surgical therapy

  6. Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy

    Bleeding on probing will be assessed dichotomously as present (1 for bleeding presence) or absent (0 for bleeding absence) within 30 seconds after probing.

    BoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

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

  7. Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy

    Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and Week 6 after completion of non-surgical therapy.

    BI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing.

    Bleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding.

    Measured: Baseline, Week 6 after non-surgical therapy

  8. Change from Baseline in bleeding index score to 12 months after surgical therapy

    Change in percentage of sites with bleeding index score (BI) from 0 to 3 will be recorded between Baseline and 12 months after completion of surgical therapy.

    BI will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) within 30 seconds after probing.

    Bleeding will be graded as: 0= no bleeding, 1= dot of bleeding, 2= line of bleeding, 3= profuse bleeding

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

  9. Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy

    Suppuration on probing (SoP) will be assessed dichotomously as present (1 for suppuration presence) or absent (0 for suppuration absence) within 30 seconds after probing.

    SoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

    Measured: Baseline, Week 6 after non-surgical therapy

  10. Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy

    Suppuration on probing (SoP) will be assessed dichotomously as present (1 for suppuration presence) or absent (0 for suppuration absence) within 30 seconds after probing.

    SoP will be recorded at 6 sites per targeted implants (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

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

  11. Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs

    Mean change in mm between week 2 and 12 months post-surgery in mean marginal bone level (mesial and distal) will be assessed using an image-processing software.

    Standardized intra-oral radiographs will be obtained at Week 2 post-surgery and at 12 months post-surgery examination, using a reproducible technique with an occlusal bite index with acrylic resin mounted on a film holder.

    Marginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact, measured at the mesial and distal aspects of the studied implants at each time-point.

    Measured: Week 2 post-surgery, 12 months post-surgery

  12. Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy

    Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed at Baseline examination and Week 6 after non-surgical therapy.

    CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

  13. Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy

    Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed at Baseline examination and Week 6 after non-surgical therapy.

    CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations 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 studied implant.

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

  14. Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy

    Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to Week 6 after completion of surgical therapy.

    CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

  15. Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy

    Mean change in mm in peri-implant clinical attachment level (CAL) will be assessed from Baseline examination to 12 months after completion of surgical therapy.

    CAL will be recorded at six sites per targeted implant. CAL will be measured in mm as the distance from the most apical portion of the crown or the prosthetic connection platform for removable implant-supported restorations 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 studied implant.

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

  16. Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy

    Mean peri-implant recession (REC) in mm will be assessed at Baseline examination and Week 6 after non-surgical therapy.

    REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

  17. Mean peri-implant recession from Baseline to 12 months after surgical therapy

    Mean peri-implant recession (REC) will be assessed in mm from Baseline examination to 12 months after surgical therapy.

    REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations 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 studied implant.

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

  18. Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy

    Mean change in mm in peri-implant recession (REC) will be assessed between Baseline examination and Week 6 after non-surgical therapy.

    REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations 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 studied implant.

    Measured: Baseline, Week 6 after non-surgical therapy

  19. Mean change from Baseline in peri-implant recession to 12 months after surgical therapy

    Mean change in mm in peri-implant recession (REC) will be assessed from Baseline examination to 12 months after completion of surgical therapy.

    REC will be recorded at six sites per targeted implant. REC will be measured in mm as the distance from the free marginal mucosa to the most apical portion of the crown or the prosthetic connection platform for removable implant- supported restorations 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 studied implant.

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

  20. Mean local plaque score from Baseline to Week 6 after non-surgical therapy

    Mean number of sites with plaque presence at targeted implants will be assessed between Baseline examination and Week 6 after non-surgical therapy.

    Local plaque score (LPS) will be calculated by assigning a binary score at each implant surface (1 for plaque presence, 0 for plaque absence) Presence or absence of plaque will be recorded at four sites per targeted implant (mesial, buccal, distal, lingual)

    Measured: Baseline, Week 6 after non-surgical therapy

  21. Mean local plaque score from Baseline to 12 months after surgical therapy

    Mean number of sites with plaque presence at targeted implants will be assessed from Baseline to 12 months after completion of surgical therapy.

    Local plaque score (LPS) will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.

    Presence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)

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

  22. Full mouth plaque score from Baseline to Week 6 after non-surgical therapy

    Percentage of full mouth plaque score (FMPS) presence from Baseline to Week 6 after completion of non-surgical therapy.

    FMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.

    Presence or absence of plaque will be recorded at four sites per tooth/ implant (mesial, buccal, distal, lingual)

    Measured: Baseline, Week 6 after non-surgical therapy

  23. Full mouth plaque score from Baseline to 12 months after surgical therapy

    Percentage of full mouth plaque score (FMPS) presence from Baseline to 12 months after completion of surgical therapy.

    FMPS will be calculated by assigning a binary score at each surface ( 1 for plaque presence, 0 for plaque absence) and calculating the percentage of total tooth/ implant surfaces with plaque presence.

    Presence or absence of plaque will be recorded at 4sites per tooth/ implant (mesial, buccal, distal, lingual)

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

  24. Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy

    Percentage of full mouth bleeding score (FMBS) presence from Baseline to Week 6 after completion of non-surgical therapy.

    FMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing.

    Presence or absence of bleeding will be recorded at six sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

    Measured: Baseline, Week 6 after non-surgical therapy

  25. Full mouth bleeding score from Baseline to 12 months after surgical therapy

    Percentage of full mouth bleeding score (FMBS) presence from Baseline to 12 months after completion of surgical therapy.

    FMBS will be calculated by assigning a binary score at each surface ( 1 for bleeding presence, 0 for bleeding absence) within 30 seconds after probing and calculating the percentage of total tooth/ implant surfaces that bled upon probing.

    Presence or absence of bleeding will be recorded at 6 sites per tooth/ implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual)

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

  26. Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery

    Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical pain using a visual analogue scale (VAS, 10cm). The following question will be asked:

    -From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

    Measured: Week 2 post-surgery

  27. Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

    Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:

    From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

    Measured: 12 months post-surgery

  28. Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

    Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:

    From 0-10, rate the intensity of pain after surgery in the treated areas. (0 represents "no pain" and 10 represents "unbearable pain").

    Measured: 12 months post-surgery

  29. Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery

    Participants will complete a questionnaire at Week 2 post-surgery in order to assess the intensity of post-surgical swelling using a visual analogue scale (VAS, 10cm). The following question will be asked:

    -From 0-10 rate the amount of post-surgery swelling in the treated areas. (0 represents "no swelling" and 10 "maximum swelling").

    Measured: Week 2 post-surgery

  30. Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery

    Participants will complete a questionnaire at 12 months post-surgery in order to assess the intensity of bleeding during toothbrushing or interdental cleaning at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:

    assess the presence and intensity of pain during toothbrushing at the treated sites at 12 months after surgery using a visual analogue scale (VAS, 10cm). The following question will be asked:

    -From 0-10 rate the amount of bleeding when applying oral hygiene to the areas you treated. (0 represents "no bleeding" and 10 "maximum bleeding").

    Measured: 12 months post-surgery

  31. Number of days of analgesic consumption at Week 2 post-surgery

    Participants will complete a questionnaire at Week 2 post-surgery in order to record the number of days analgesics were needed .

    Measured: Week 2 post-surgery

  32. Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery

    Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:

    -If necessary, would you do this treatment again? (0 represents aversion to repeating the treatment and 10 that you would repeat it comfortably).

    Measured: Week 2 post-surgery

  33. Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery

    Participants will complete a questionnaire at Week 2 post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:

    -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

    Measured: Week 2 post-surgery

  34. Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery

    Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:

    -Are you satisfied with the treatment you received? (0 represents "not at all satisfied" and 10 "completely satisfied").

    Measured: 12 months post-surgery

  35. Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery

    Participants will complete a questionnaire at 12 months post-surgery in order to assess satisfaction with the treatment provided using a visual analogue scale (VAS, 10cm). The followed questions will be asked:

    -Would you recommend the treatment to a relative or friend? (0 represents that you would not recommend it under any circumstances and 10 that you would absolutely recommend it, if necessary).

    Measured: 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start28 Jul 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The experimental protocol is designed as a double-blind, randomized clinical trial with a 12-month duration and a parallel design
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899933
Sponsor's protocol ID
PERIO1
Status last verified
Apr 2026
First submitted
2 Jun 2023
Last updated
15 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that supports the findings of this study will be available from the corresponding author upon reasonable request.

Publications

  • Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.

    PubMed 26285807

  • Casado PL, Otazu IB, Balduino A, de Mello W, Barboza EP, Duarte ME. Identification of periodontal pathogens in healthy periimplant sites. Implant Dent. 2011 Jun;20(3):226-35. doi: 10.1097/ID.0b013e3182199348.

    PubMed 21613949

  • Charalampakis G, Belibasakis GN. Microbiome of peri-implant infections: lessons from conventional, molecular and metagenomic analyses. Virulence. 2015;6(3):183-7. doi: 10.4161/21505594.2014.980661. Epub 2015 Feb 5.

    PubMed 25654499

  • Charalampakis G, Rabe P, Leonhardt A, Dahlen G. A follow-up study of peri-implantitis cases after treatment. J Clin Periodontol. 2011 Sep;38(9):864-71. doi: 10.1111/j.1600-051X.2011.01759.x. Epub 2011 Jul 19.

    PubMed 21770994

  • Dabdoub SM, Tsigarida AA, Kumar PS. Patient-specific analysis of periodontal and peri-implant microbiomes. J Dent Res. 2013 Dec;92(12 Suppl):168S-75S. doi: 10.1177/0022034513504950. Epub 2013 Oct 24.

    PubMed 24158341

  • Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.

    PubMed 24660207

  • Lasserre JF, Brecx MC, Toma S. Implantoplasty Versus Glycine Air Abrasion for the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2020 Jan/Feb;35(35):197-206. doi: 10.11607/jomi.6677.

    PubMed 31923303

  • Maximo MB, de Mendonca AC, Renata Santos V, Figueiredo LC, Feres M, Duarte PM. Short-term clinical and microbiological evaluations of peri-implant diseases before and after mechanical anti-infective therapies. Clin Oral Implants Res. 2009 Jan;20(1):99-108. doi: 10.1111/j.1600-0501.2008.01618.x.

    PubMed 19126114

  • Mombelli A, Decaillet F. The characteristics of biofilms in peri-implant disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:203-13. doi: 10.1111/j.1600-051X.2010.01666.x.

    PubMed 21323716

  • Perez-Chaparro PJ, Duarte PM, Shibli JA, Montenegro S, Lacerda Heluy S, Figueiredo LC, Faveri M, Feres M. The Current Weight of Evidence of the Microbiologic Profile Associated With Peri-Implantitis: A Systematic Review. J Periodontol. 2016 Nov;87(11):1295-1304. doi: 10.1902/jop.2016.160184. Epub 2016 Jul 15.

    PubMed 27420109

  • Persson GR, Renvert S. Cluster of bacteria associated with peri-implantitis. Clin Implant Dent Relat Res. 2014 Dec;16(6):783-93. doi: 10.1111/cid.12052. Epub 2013 Mar 25.

    PubMed 23527870

  • Pommer B, Haas R, Mailath-Pokorny G, Furhauser R, Watzek G, Busenlechner D, Muller-Kern M, Kloodt C. Periimplantitis Treatment: Long-Term Comparison of Laser Decontamination and Implantoplasty Surgery. Implant Dent. 2016 Oct;25(5):646-9. doi: 10.1097/ID.0000000000000461.

    PubMed 27504533

  • Renvert S, Polyzois I. Treatment of pathologic peri-implant pockets. Periodontol 2000. 2018 Feb;76(1):180-190. doi: 10.1111/prd.12149. Epub 2017 Nov 29.

    PubMed 29239086

  • Romeo E, Ghisolfi M, Murgolo N, Chiapasco M, Lops D, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part I: clinical outcome. Clin Oral Implants Res. 2005 Feb;16(1):9-18. doi: 10.1111/j.1600-0501.2004.01084.x.

    PubMed 15642026

  • Romeo E, Lops D, Chiapasco M, Ghisolfi M, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part II: radiographic outcome. Clin Oral Implants Res. 2007 Apr;18(2):179-87. doi: 10.1111/j.1600-0501.2006.01318.x.

    PubMed 17348882

Questions about this trial

What is this clinical trial studying?

A study testing Non-surgical peri-implant therapy, Implantoplasty and Erythritol Air-abrasive device in people with Peri-Implantitis and Peri-Implant Health, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yiorgos A. Bobetsis, Assistant Professor ((+30) 210-746-1097, ybobetsi@dent.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 months post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05899933, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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