Clinical trial NCT06762353: SPIC Frequency After Surgical Treatment of Peri-implantitis
Official title: Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2025-01-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Treatment success - criterion 1 (yes/no)
timeFrame: 1 year
measure: Implant loss (yes/no)
timeFrame: 5 years
Secondary outcomes:
measure: Implant loss (yes/no)
timeFrame: 1 and 3 years
measure: Treatment success - criterion 1
timeFrame: 3 and 5 years
measure: Treatment success - criterion 2 (yes/no)
timeFrame: 1, 3, and 5 years
measure: Plaque presence (yes/no)
timeFrame: 1, 3 and 5 years
measure: Plaque extent
timeFrame: 1, 3 and 5 years
measure: Probing pocket depth (mm)
timeFrame: 1, 3 and 5 years
measure: Bleeding on deep probing (yes/no)
timeFrame: 1, 3 and 5 years
measure: Soft-tissue level margin (mm)
timeFrame: 1, 3 and 5 years
measure: Keratinised mucosa height (mm)
timeFrame: 1, 3 and 5 years
measure: Bleeding on superficial probing
timeFrame: 1, 3 and 5 years
measure: Suppuration (yes/no)
timeFrame: 1, 3 and 5 years
measure: Modified Bleeding Index
timeFrame: 1, 3 and 5 years
measure: Radiographic outcomes
timeFrame: 1, 3 and 5 years
measure: Patient- and clinician- esthetic appreciation
timeFrame: Assessed at 1, 3 and 5 years
measure: Total SPIC duration (months)
timeFrame: Assessed at 1, 3 and 5 years
measure: Number of sub-marginal re-instrumentations at study implants
timeFrame: Assessed at 1, 3 and 5 years
measure: Compliance to SPIC regimen (yes/no)
timeFrame: Assessed at 1, 3 and 5 years
measure: Number of surgical retreatments
timeFrame: Assessed at 1, 3 and 5 years
measure: Rate of adverse events
timeFrame: Assessed at 1, 3 and 5 years
measure: Full-mouth plaque score (0-100)
timeFrame: 1, 3, and 5 years
measure: Full-mouth bleeding score (0-100)
timeFrame: 1, 3, and 5 years
measure: Clinical attachment level around remaining teeth
timeFrame: 1, 3, and 5 years
measure: Chairside aMMP-8 assay (positive/negative)
timeFrame: 1, 3, and 5 years
measure: Molecular analysis in the peri-implant crevicular fluid
timeFrame: 1 month, 6 months, 1, 3 and 5 years
measure: Microbiological analysis
timeFrame: 1 month, 6 months, 1, 3, and 5 years
Other outcomes:
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