A Phase 4 interventional study of ultrasonic and erythritol in Peri-Implantitis and Peri-implant Mucositis, sponsored by Proed, Torino, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-02.
Sponsored by Proed, Torino, Italy · Phase 4, Interventional, and Treatment
20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included.
Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Proed, Torino, Italy is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: ultrasonic · Procedure: erythritol · Drug: metronidazole gel
probing pocket depth change
Time frame: baseline, 6 months
bleeding on probing change
Time frame: baseline, 6 months
clinical attachment level change
Time frame: baseline, 6 months
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Proed, Torino, Italy