SPIC Frequency After Surgical Treatment of Peri-implantitis

N/ANot Yet RecruitingNCT06762353

University of Turin, Italy152 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Peri-Implantitis

Interventions

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 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 year

Implant loss (yes/no)

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

Time frame: 5 years

Secondary Outcomes

Implant loss (yes/no)

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

Time frame: 1 and 3 years

Treatment success - criterion 1

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

Time frame: 3 and 5 years

Treatment success - criterion 2 (yes/no)

Absence of: implant loss, bone loss \>1 mm and surgical re-treatments.

Time frame: 1, 3, and 5 years

Plaque presence (yes/no)

Presence of plaque (binary - presence/absence in at least 1 site)

Time frame: 1, 3 and 5 years

Plaque extent

Plaque extent (continuous - number of sites per implant: 0-6 sites)

Time frame: 1, 3 and 5 years

Probing pocket depth (mm)

Probing pocket depth (continuous - assessed at the deepest site per implant)

Time frame: 1, 3 and 5 years

Bleeding on deep probing (yes/no)

Bleeding on deep probing (binary - presence/absence in at least 1 site)

Time frame: 1, 3 and 5 years

Soft-tissue level margin (mm)

Peri-implant soft-tissue margin level from a constant fixed reference point (continuous - greatest implant level increase among the 6 sites)

Time frame: 1, 3 and 5 years

Keratinised mucosa height (mm)

Keratinized mucosa height (continuous - midbuccal aspect)

Time frame: 1, 3 and 5 years

Bleeding on superficial probing

Bleeding on superficial circumferential probing (categorical - highest implant level value: 0=no sBoP, 1= isolated bleeding spots; 2=confluent red line on margin; 3=heavy or profuse bleeding)

Time frame: 1, 3 and 5 years

Suppuration (yes/no)

Suppuration on deep probing (binary - presence/absence in at least 1 site).

Time frame: 1, 3 and 5 years

Modified Bleeding Index

Modified Bleeding Index after profound probing (categorical - highest implant level value: 0=no dBoP; 1=isolated bleeding spots; 2=confluent red line on margin; 3=heavy or profuse bleeding)

Time frame: 1, 3 and 5 years

Radiographic outcomes

Taking into account the worst site-specific (between mesial and distal) change: bone level change, bone gain \>0.5 mm, bone loss \>0.5 mm.

Time frame: 1, 3 and 5 years

Patient- and clinician- esthetic appreciation

Assessment on a 100 mm visual analogue scale (VAS) of both patient- and clinician- esthetic appreciation and overall patient satisfaction.