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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Non-surgical peri-implant therapy
  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), tit
• Процедура Implantoplasty
  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 wh
• Процедура Erythritol Air-abrasive device
  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 w
• Процедура Prophylaxis
  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

Первичные конечные точки

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit]

Вторичные конечные точки (12)

• Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy [Срок оценки: Baseline, Week 6 after non-surgical therapy]
• Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy [Срок оценки: 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 [Срок оценки: Baseline, Week 6 after non-surgical therapy]
• Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy [Срок оценки: 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 [Срок оценки: Baseline, Week 6 after non-surgical therapy]
• Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy [Срок оценки: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery]
• Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy [Срок оценки: Baseline, Week 6 after non-surgical therapy]
• Change from Baseline in bleeding index score to 12 months after surgical therapy [Срок оценки: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery]
• Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy [Срок оценки: Baseline, Week 6 after non-surgical therapy]
• Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy [Срок оценки: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery]
• Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs [Срок оценки: Week 2 post-surgery, 12 months post-surgery]
• Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy [Срок оценки: Baseline, Week 6 after non-surgical therapy]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

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

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 19126114

Идентификаторы

NCT: NCT05899933 · PERIO1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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