An interventional study of 3-month supportive peri-implant care (SPIC) and 6-month supportive peri-implant care (SPIC) in Peri-Implantitis, sponsored by University of Turin, Italy. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by University of Turin, Italy · Not applicable, Interventional, and Treatment
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.
313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.
This study's planned enrollment of 152 is above the median of 40 across 191 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →University of Turin, Italy is the lead sponsor of 213 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Local primary exclusion criteria:
A secondary inclusion criterion will be applied 1-month after surgery:
- absence of peri-implant abscess on the implants to be included.
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)
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)
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.
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.
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
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.
Time frame: Assessed at 1, 3 and 5 years
Total SPIC duration (months)
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
Time frame: Assessed at 1, 3 and 5 years
Number of sub-marginal re-instrumentations at study implants
Number of sub-marginal re-instrumentations at study implants during SPIC appointments
Time frame: Assessed at 1, 3 and 5 years
Compliance to SPIC regimen (yes/no)
Compliance to SPIC regimen according to patient randomisation
Time frame: Assessed at 1, 3 and 5 years
Number of surgical retreatments
Number of surgical retreatments performed on the study implant during the study time
Time frame: Assessed at 1, 3 and 5 years
Rate of adverse events
Rate of adverse events occurred during the study time, both dependent and independent of the study procedures
Time frame: Assessed at 1, 3 and 5 years
Full-mouth plaque score (0-100)
A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing plaque (presence/absence)
Time frame: 1, 3, and 5 years
Full-mouth bleeding score (0-100)
A full-mouth periodontal examination around the remaining dentition (6 sites per tooth/implant) will be performed assessing Bleeding on Probing (presence/absence),
Time frame: 1, 3, and 5 years
Clinical attachment level around remaining teeth
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.
Time frame: 1, 3, and 5 years
Chairside aMMP-8 assay (positive/negative)
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.
Time frame: 1, 3, and 5 years
Molecular analysis in the peri-implant crevicular fluid
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.
Time frame: 1 month, 6 months, 1, 3 and 5 years
Microbiological analysis
Shotgun metagenomics will be used to monitor the microbiological profile associated to the clinical condition.
Time frame: 1 month, 6 months, 1, 3, and 5 years
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Sep 2031, 79 months later.
Of 117 non-industry interventional studies with no phase under Peri-Implantitis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 79 months is above that.
Counting every sponsor, half of 124 studies reached it within 26 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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