SPIC Frequency After Surgical Treatment of Peri-implantitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-month supportive peri-implant care (SPIC), 6-month supportive peri-implant care (SPIC).
- Who it may be relevant to
- Registry conditions: Peri-Implantitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial
Overview
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.
Interventions
- Procedure 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/ - Procedure 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/
Primary outcome measures
- Treatment success - criterion 1 (yes/no) [Time frame: 1 year]
- Implant loss (yes/no) [Time frame: 5 years]
Secondary outcome measures (12)
- Implant loss (yes/no) [Time frame: 1 and 3 years]
- Treatment success - criterion 1 [Time frame: 3 and 5 years]
- Treatment success - criterion 2 (yes/no) [Time frame: 1, 3, and 5 years]
- Plaque presence (yes/no) [Time frame: 1, 3 and 5 years]
- Plaque extent [Time frame: 1, 3 and 5 years]
- Probing pocket depth (mm) [Time frame: 1, 3 and 5 years]
- Bleeding on deep probing (yes/no) [Time frame: 1, 3 and 5 years]
- Soft-tissue level margin (mm) [Time frame: 1, 3 and 5 years]
- Keratinised mucosa height (mm) [Time frame: 1, 3 and 5 years]
- Bleeding on superficial probing [Time frame: 1, 3 and 5 years]
- Suppuration (yes/no) [Time frame: 1, 3 and 5 years]
- Modified Bleeding Index [Time frame: 1, 3 and 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06762353 · SPIC Multi-center