SPIC Frequency After Surgical Treatment of Peri-implantitis

Официальное название

Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial

Обзор

The leading hypothesis behind this study is that a 3-month frequency of supportive peri-implant care (SPIC) recalls after surgical therapy of implants affected by severe peri-implantitis yields better results when compared to a 6-month frequency. Thus, the primary aim of this randomized clinical trial is to compare 2 different frequencies of SPIC recalls (3 and 6 months) after surgical treatment of severe peri-implantitis in terms of treatment success (absence of implant loss, probing pocket depth (PPD) ≤ 5 mm at all aspects, bleeding on deep probing ≤1 site/implant, no suppuration at all aspects, bone loss \<0.5 mm) at early follow-up (1-year) and implant survival at the 5-year examination. Secondarily, this randomized clinical trial aims to assess the effects of the 2 different frequencies over clinical attachment levels around remaining teeth.

Вмешательства

• Процедура 3-month supportive peri-implant care (SPIC)
  SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD \>4 mm with BoP/SoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and/
• Процедура 6-month supportive peri-implant care (SPIC)
  SPIC including update on smoking status, evaluation of the patient's adherence to self-performed oral hygiene procedures, full-mouth supra-gingival instrumentation around teeth, repeated sub-gingival instrumentation on sites presenting a PPD \>4 mm with BoP/SoP or a PPD≥6 mm, supra-marginal instrumentation around implants, using an erythritol air abrasive system and interdental brushes, sub-marginal instrumentation on implants with BoP after deep probing by an erythritol air abrasive system and/

Первичные конечные точки

• Treatment success - criterion 1 (yes/no) [Срок оценки: 1 year]
• Implant loss (yes/no) [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Implant loss (yes/no) [Срок оценки: 1 and 3 years]
• Treatment success - criterion 1 [Срок оценки: 3 and 5 years]
• Treatment success - criterion 2 (yes/no) [Срок оценки: 1, 3, and 5 years]
• Plaque presence (yes/no) [Срок оценки: 1, 3 and 5 years]
• Plaque extent [Срок оценки: 1, 3 and 5 years]
• Probing pocket depth (mm) [Срок оценки: 1, 3 and 5 years]
• Bleeding on deep probing (yes/no) [Срок оценки: 1, 3 and 5 years]
• Soft-tissue level margin (mm) [Срок оценки: 1, 3 and 5 years]
• Keratinised mucosa height (mm) [Срок оценки: 1, 3 and 5 years]
• Bleeding on superficial probing [Срок оценки: 1, 3 and 5 years]
• Suppuration (yes/no) [Срок оценки: 1, 3 and 5 years]
• Modified Bleeding Index [Срок оценки: 1, 3 and 5 years]

Критерии участия

Any patient aged 18 years or more, who has at least one implant affected by severe peri-implantitis, and able to sign an informed consent form will be potentially eligible for this trial. Severe peri-implantitis will be defined as the presence of a peri-implant probing pocket depth \[PPD\] ≥ 6 mm in at least 1 site of the implant, bleeding and/or suppuration on deep probing \[dBoP and/or dSoP, respectively\] and radiographically documented marginal bone loss > 3 mm (Carcuac et al. 2016; Romandini et al. 2022) on implants in function by at least 12-months. In the absence of baseline radiographs, implants had to present a bone level >3 mm (Romandini et al. 2021b).

Patients fulfilling the above-mentioned inclusion criteria will not be included in the study if they appear to be unable to attend the study-related procedures (including the long-term follow-up visits) or if one or more of the following systemic or local exclusion criteria are detected during the enrolment phase.

Systemic primary exclusion criteria:

• systemic diseases (e.g. uncontrolled diabetes mellitus) or chronic use of medications (e.g. corticosteroids, bisphosphonates) likely to influence the outcome of therapy or which contraindicates the study procedures;
• smoking >10 cigarettes;
• pregnant or nursing women.

Local primary exclusion criteria:

• history of peri-implantitis treatment on the eligible implants in the previous 6 months;
• hopeless implants (>80% of bone loss/level).

A secondary inclusion criterion will be applied 1-month after surgery:

\- absence of peri-implant abscess on the implants to be included.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06762353 · SPIC Multi-center

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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