Health TrialsbyHealthPanel

SPIC Frequency After Surgical Treatment of Peri-implantitis

ConditionPeri-Implantitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Turin, Italy

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

history of peri-implantitis treatment on the eligible implants in the previous 6 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3-month supportive peri-implant care (SPIC)

    Procedure/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/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.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: 3-month frequency of supportive peri-implant care (SPIC)Experimental treatment 1 intervention
Group B: 6-month frequency of supportive peri-implant care (SPIC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Implant loss (yes/no)

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

Time frame
5 years

Secondary outcomes

1

Implant loss (yes/no)

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

Time frame
1 and 3 years
2

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
3

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
4

Plaque presence (yes/no)

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

Time frame
1, 3 and 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Turin, Italy

Lead sponsor

Ege University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: