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NCT Number: NCT06762353

SPIC Frequency After Surgical Treatment of Peri-implantitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Treatment success - criterion 1 (yes/no)

    Time frame: 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

  2. Implant loss (yes/no)

    Time frame: 5 years

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

Secondary outcomes

  1. Implant loss (yes/no)

    Time frame: 1 and 3 years

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

  2. Treatment success - criterion 1

    Time frame: 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

  3. Treatment success - criterion 2 (yes/no)

    Time frame: 1, 3, and 5 years

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

  4. Plaque presence (yes/no)

    Time frame: 1, 3 and 5 years

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

  5. Plaque extent

    Time frame: 1, 3 and 5 years

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

  6. Probing pocket depth (mm)

    Time frame: 1, 3 and 5 years

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

  7. Bleeding on deep probing (yes/no)

    Time frame: 1, 3 and 5 years

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

  8. Soft-tissue level margin (mm)

    Time frame: 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)

  9. Keratinised mucosa height (mm)

    Time frame: 1, 3 and 5 years

    Keratinized mucosa height (continuous - midbuccal aspect)

  10. Bleeding on superficial probing

    Time frame: 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)

  11. Suppuration (yes/no)

    Time frame: 1, 3 and 5 years

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

  12. Modified Bleeding Index

    Time frame: 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)

  13. Radiographic outcomes

    Time frame: 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.

  14. Patient- and clinician- esthetic appreciation

    Time frame: 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.

  15. Total SPIC duration (months)

    Time frame: 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

  16. Number of sub-marginal re-instrumentations at study implants

    Time frame: Assessed at 1, 3 and 5 years

    Number of sub-marginal re-instrumentations at study implants during SPIC appointments

  17. Compliance to SPIC regimen (yes/no)

    Time frame: Assessed at 1, 3 and 5 years

    Compliance to SPIC regimen according to patient randomisation

  18. Number of surgical retreatments

    Time frame: Assessed at 1, 3 and 5 years

    Number of surgical retreatments performed on the study implant during the study time

  19. Rate of adverse events

    Time frame: Assessed at 1, 3 and 5 years

    Rate of adverse events occurred during the study time, both dependent and independent of the study procedures

  20. Full-mouth plaque score (0-100)

    Time frame: 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)

  21. Full-mouth bleeding score (0-100)

    Time frame: 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),

  22. Clinical attachment level around remaining teeth

    Time frame: 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.

  23. Chairside aMMP-8 assay (positive/negative)

    Time frame: 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.

  24. Molecular analysis in the peri-implant crevicular fluid

    Time frame: 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.

  25. Microbiological analysis

    Time frame: 1 month, 6 months, 1, 3, and 5 years

    Shotgun metagenomics will be used to monitor the microbiological profile associated to the clinical condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Baima, PhD

CONTACT

[email protected]

011 6331546

Mario Romandini

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Ege University

Registry information

Official study title

Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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