SPIC Frequency After Surgical Treatment of Peri-implantitis

NCT06762353 | Not Yet Recruiting

• 1 other identifier: SPIC Multi-center
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Treatment success - criterion 1 (yes/no)

  Absence of implant loss, probing pocket depth ≤ 5 mm at all aspects, deep bleeding/suppuration on probing ≤1 site/implant, bone loss \<0.5 mm

  1 year

• Implant loss (yes/no)

  Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.

  5 years

Secondary Outcomes (25)

• Implant loss (yes/no)

  1 and 3 years

• Treatment success - criterion 1

  3 and 5 years

• Treatment success - criterion 2 (yes/no)

  1, 3, and 5 years

• Plaque presence (yes/no)

  1, 3 and 5 years

• Plaque extent

  1, 3 and 5 years

Study Arms (2)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

3-month supportive peri-implant care (SPIC) 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.

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

6-month supportive peri-implant care (SPIC) 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• University of Turin, Italy: lead
• Ege University: collaborator

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Giacomo Baima, PhD

CONTACT

011 6331546; giacomo.baima@unito.it

Mario Romandini

CONTACT

mario.romandini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator (together with Mario Romandini)

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 7, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): September 15, 2031
• Study Completion (Estimated): September 15, 2031
• Last Updated: January 7, 2025

Record last verified: 2024-12