Clinical Trial: Non Surgical Treatment of Periimplantitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
Brief Summary:
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).
Detailed Summary:
Sponsor: Proed
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Proed
Dates:
Date Received: December 18, 2013
Date Started: December 2013
Date Completion:
Last Updated: September 1, 2016
Last Verified: September 2016
