Clinical trial NCT05899933: Comparison of the Effectiveness of Two Different Surgical Therapeutic Protocols of Peri-implantitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Peri-Implant Health
Keywords: Peri-Implantitis
Surgical therapy
Implantoplasty
Air-abrasive device
Erythritol powder
Peri-Implant microbiota
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental protocol is designed as a double-blind, randomized clinical trial with a 12-month duration and a parallel design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 months post-surgery
measure: 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
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: 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
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: 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
timeFrame: Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit
Secondary outcomes:
measure: Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Change from Baseline in bleeding index score to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs
timeFrame: Week 2 post-surgery, 12 months post-surgery
measure: Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean peri-implant recession from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean change from Baseline in peri-implant recession to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Mean local plaque score from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Mean local plaque score from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Full mouth plaque score from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Full mouth plaque score from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy
timeFrame: Baseline, Week 6 after non-surgical therapy
measure: Full mouth bleeding score from Baseline to 12 months after surgical therapy
timeFrame: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
measure: Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery
timeFrame: Week 2 post-surgery
measure: Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery
timeFrame: Week 2 post-surgery
measure: Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Number of days of analgesic consumption at Week 2 post-surgery
timeFrame: Week 2 post-surgery
measure: Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery
timeFrame: Week 2 post-surgery
measure: Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery
timeFrame: Week 2 post-surgery
measure: Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Phoebus N. Madianos
role: STUDY_CHAIR
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