Peri-Implantitis
Conditions
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.
Interventions
PROCEDURE3-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.
PROCEDURE6-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.
Sponsors
Ege University
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success - criterion 1 (yes/no) | 1 year | 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 |
| Implant loss (yes/no) | 5 years | Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success - criterion 2 (yes/no) | 1, 3, and 5 years | Absence of: implant loss, bone loss \>1 mm and surgical re-treatments. |
| Plaque presence (yes/no) | 1, 3 and 5 years | Presence of plaque (binary - presence/absence in at least 1 site) |
| Plaque extent | 1, 3 and 5 years | Plaque extent (continuous - number of sites per implant: 0-6 sites) |
| Probing pocket depth (mm) | 1, 3 and 5 years | Probing pocket depth (continuous - assessed at the deepest site per implant) |
| Bleeding on deep probing (yes/no) | 1, 3 and 5 years | Bleeding on deep probing (binary - presence/absence in at least 1 site) |
| Soft-tissue level margin (mm) | 1, 3 and 5 years | Peri-implant soft-tissue margin level from a constant fixed reference point (continuous - greatest implant level increase among the 6 sites) |
| Keratinised mucosa height (mm) | 1, 3 and 5 years | Keratinized mucosa height (continuous - midbuccal aspect) |
| Bleeding on superficial probing | 1, 3 and 5 years | 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) |
| Suppuration (yes/no) | 1, 3 and 5 years | Suppuration on deep probing (binary - presence/absence in at least 1 site). |
| Modified Bleeding Index | 1, 3 and 5 years | 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) |
| Radiographic outcomes | 1, 3 and 5 years | 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. |
| Implant loss (yes/no) | 1 and 3 years | Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration. |
| Total SPIC duration (months) | Assessed at 1, 3 and 5 years | Total supportive peri-implant care duration in months , number of sub-marginal re-instrumentations at study implants during SPIC appointments, compliance to SPIC regimen, number of surgical retreatments, and rate of adverse events |
| Number of sub-marginal re-instrumentations at study implants | Assessed at 1, 3 and 5 years | Number of sub-marginal re-instrumentations at study implants during SPIC appointments |
| Compliance to SPIC regimen (yes/no) | Assessed at 1, 3 and 5 years | Compliance to SPIC regimen according to patient randomisation |
| Number of surgical retreatments | Assessed at 1, 3 and 5 years | Number of surgical retreatments performed on the study implant during the study time |
| Rate of adverse events | Assessed at 1, 3 and 5 years | Rate of adverse events occurred during the study time, both dependent and independent of the study procedures |
| Full-mouth plaque score (0-100) | 1, 3, and 5 years | A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing plaque (presence/absence) |
| Full-mouth bleeding score (0-100) | 1, 3, and 5 years | A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing Bleeding on Probing (presence/absence), |
| Clinical attachment level around remaining teeth | 1, 3, and 5 years | Probing pocket depth (PPD) and recession (REC) (negative values when the CEJ is located subgingivally, positive otherwise). Clinical attachment levels (CAL) will be calculated by summing PPD and REC values for each site. Patient-level incidence of clinical attachment loss \>2 mm around teeth will be evaluated as a further outcome. |
| Chairside aMMP-8 assay (positive/negative) | 1, 3, and 5 years | Chairside active matrix metalloprotease-8 (aMMP-8) assay will be conducted at the study implant site. Positivity will be determined using a threshold value of ≥20 ng/mL. |
| Molecular analysis in the peri-implant crevicular fluid | 1 month, 6 months, 1, 3 and 5 years | Cytokines expressed in the peri-implant crevicular fluid will be monitored as additional outcomes to study the mechanistic interplays involved in the potential different clinical response between groups. |
| Microbiological analysis | 1 month, 6 months, 1, 3, and 5 years | Shotgun metagenomics will be used to monitor the microbiological profile associated to the clinical condition. |
| Patient- and clinician- esthetic appreciation | Assessed at 1, 3 and 5 years | Assessment on a 100 mm visual analogue scale (VAS) of both patient- and clinician- esthetic appreciation and overall patient satisfaction. |
| Treatment success - criterion 1 | 3 and 5 years | 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 |
Contacts
Primary ContactGiacomo Baima, PhD
Backup ContactMario Romandini
Outcome results
None listed