SPIC Frequency After Surgical Treatment of Peri-implantitis

University of Turin

Status: Not yet enrolling

Conditions: Peri-Implantitis

Treatments: Procedure: 3-month supportive peri-implant care (SPIC); Procedure: 6-month supportive peri-implant care (SPIC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06762353

SPIC Multi-center

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

152 participants in 2 patient groups

3-month frequency of supportive peri-implant care (SPIC)

Experimental group

Description:

SPIC provided at a 3-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.

Treatment:

Procedure: 3-month supportive peri-implant care (SPIC)

6-month frequency of supportive peri-implant care (SPIC)

Active Comparator group

Description:

SPIC provided at a 6-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis.

Treatment:

Procedure: 6-month supportive peri-implant care (SPIC)