SPIC Frequency After Surgical Treatment of Peri-implantitis

NCT ID: NCT06762353

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2031-09-15

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.

Conditions

Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

3-month supportive peri-implant care (SPIC)

Intervention Type: PROCEDURE

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/or ultrasonic scaler provided at a 3-month frequency after surgical treatment of peri-implantitis.

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

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

Group Type: ACTIVE_COMPARATOR

6-month supportive peri-implant care (SPIC)

Intervention Type: PROCEDURE

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/or ultrasonic scaler provided at a 6-month frequency after surgical treatment of peri-implantitis.

Interventions

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/or ultrasonic scaler provided at a 3-month frequency after surgical treatment of peri-implantitis.

Intervention Type: 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/or ultrasonic scaler provided at a 6-month frequency after surgical treatment of peri-implantitis.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Giacomo Baima

Co-Principal Investigator (together with Mario Romandini)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Giacomo Baima, PhD

Role: CONTACT

giacomo.baima@unito.it

011 6331546

Mario Romandini

Role: CONTACT

mario.romandini@gmail.com

Other Identifiers

SPIC Multi-center

Identifier Type: -

Identifier Source: org_study_id