Peri-ImplantitisNCT06762353
SPIC Frequency After Surgical Treatment of Peri-implantitis
A study testing 3-month supportive peri-implant care (SPIC) and 6-month supportive peri-implant care (SPIC) in people with Peri-Implantitis, run by University of Turin, Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- 3-month supportive peri-implant care (SPIC) and 6-month supportive peri-implant care (SPIC)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 15 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mario Romandini contact
About this study
Official title: Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial
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.
- Conditions
- Peri-Implantitis
- Being tested
- 3-month supportive peri-implant care (SPIC), 6-month supportive peri-implant care (SPIC)
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month supportive peri-implant care (SPIC)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-month frequency of supportive peri-implant care (SPIC) | Experimental | SPIC provided at a 3-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis. Receives: Procedure: 3-month supportive peri-implant care (SPIC) |
| 6-month frequency of supportive peri-implant care (SPIC) | Active comparator | SPIC provided at a 6-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis. Receives: Procedure: 6-month supportive peri-implant care (SPIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Implant loss (yes/no)
Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.
Measured: 5 years
Secondary outcomes (25)
Implant loss (yes/no)
Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.
Measured: 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
Measured: 3 and 5 years
Treatment success - criterion 2 (yes/no)
Absence of: implant loss, bone loss >1 mm and surgical re-treatments.
Measured: 1, 3, and 5 years
Plaque presence (yes/no)
Presence of plaque (binary - presence/absence in at least 1 site)
Measured: 1, 3 and 5 years
Plaque extent
Plaque extent (continuous - number of sites per implant: 0-6 sites)
Measured: 1, 3 and 5 years
Probing pocket depth (mm)
Probing pocket depth (continuous - assessed at the deepest site per implant)
Measured: 1, 3 and 5 years
Bleeding on deep probing (yes/no)
Bleeding on deep probing (binary - presence/absence in at least 1 site)
Measured: 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)
Measured: 1, 3 and 5 years
Keratinised mucosa height (mm)
Keratinized mucosa height (continuous - midbuccal aspect)
Measured: 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)
Measured: 1, 3 and 5 years
Suppuration (yes/no)
Suppuration on deep probing (binary - presence/absence in at least 1 site).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Assessed at 1, 3 and 5 years
Compliance to SPIC regimen (yes/no)
Compliance to SPIC regimen according to patient randomisation
Measured: Assessed at 1, 3 and 5 years
Number of surgical retreatments
Number of surgical retreatments performed on the study implant during the study time
Measured: 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
Measured: 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)
Measured: 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),
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month, 6 months, 1, 3, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion15 Sep 2031 (estimated)
- Study completion15 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Giacomo Baima, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762353
- Sponsor's protocol ID
- SPIC Multi-center
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06762353
- Acronym / sponsor ID
- SPIC Multi-center
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 15 Sep 2031 (estimated)
- Study completion
- 15 Sep 2031 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-month frequency of supportive peri-implant care (SPIC) | Experimental | Procedure: 3-month supportive peri-implant care (SPIC)SPIC provided at a 3-month frequency starting from the 1-month re-evaluation after surgical treatment of peri-implantitis. |
| 6-month frequency of supportive peri-implant care (SPIC) | Active comparator | Procedure: 6-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-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. | Procedure or surgery | 3-month frequency of supportive peri-implant care (SPIC) |
| 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 6-month frequency after surgical treatment of peri-implantitis. | Procedure or surgery | 6-month frequency of supportive peri-implant care (SPIC) |
Primary outcome
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
Implant loss (yes/no)
Time frame: 5 years
Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.
25 secondary outcomes
Implant loss (yes/no)
Time frame: 1 and 3 years
Treatment success - criterion 1
Time frame: 3 and 5 years
Treatment success - criterion 2 (yes/no)
Time frame: 1, 3, and 5 years
Plaque presence (yes/no)
Time frame: 1, 3 and 5 years
Plaque extent
Time frame: 1, 3 and 5 years
Probing pocket depth (mm)
Time frame: 1, 3 and 5 years
Bleeding on deep probing (yes/no)
Time frame: 1, 3 and 5 years
Soft-tissue level margin (mm)
Time frame: 1, 3 and 5 years
Keratinised mucosa height (mm)
Time frame: 1, 3 and 5 years
Bleeding on superficial probing
Time frame: 1, 3 and 5 years
Suppuration (yes/no)
Time frame: 1, 3 and 5 years
Modified Bleeding Index
Time frame: 1, 3 and 5 years
Radiographic outcomes
Time frame: 1, 3 and 5 years
Patient- and clinician- esthetic appreciation
Time frame: Assessed at 1, 3 and 5 years
Total SPIC duration (months)
Time frame: Assessed at 1, 3 and 5 years
Number of sub-marginal re-instrumentations at study implants
Time frame: Assessed at 1, 3 and 5 years
Compliance to SPIC regimen (yes/no)
Time frame: Assessed at 1, 3 and 5 years
Number of surgical retreatments
Time frame: Assessed at 1, 3 and 5 years
Rate of adverse events
Time frame: Assessed at 1, 3 and 5 years
Full-mouth plaque score (0-100)
Time frame: 1, 3, and 5 years
Full-mouth bleeding score (0-100)
Time frame: 1, 3, and 5 years
Clinical attachment level around remaining teeth
Time frame: 1, 3, and 5 years
Chairside aMMP-8 assay (positive/negative)
Time frame: 1, 3, and 5 years
Molecular analysis in the peri-implant crevicular fluid
Time frame: 1 month, 6 months, 1, 3 and 5 years
Microbiological analysis
Time frame: 1 month, 6 months, 1, 3, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Romandini contact
Questions about this trial
What is this clinical trial studying?
A study testing 3-month supportive peri-implant care (SPIC) and 6-month supportive peri-implant care (SPIC) in people with Peri-Implantitis, run by University of Turin, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Baima, PhD (011 6331546, giacomo.baima@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success - criterion 1 (yes/no) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.