SPIC Frequency After Surgical Treatment of Peri-implantitis

Not Applicable

Not yet recruiting

• Conditions: Peri-Implantitis

• Registration Number: NCT06762353
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-01-20
• Primary Completion: 2031-09-15
• Study Completion: 2031-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Implant loss (yes/no)	1 and 3 years	Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.
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
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.
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.
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.