Non Surgical Treatment of Periimplantitis
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|ClinicalTrials.gov Identifier: NCT02023853|
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : September 2, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Peri-Implantitis and Peri-implant Mucositis||Procedure: ultrasonic Procedure: erythritol Drug: metronidazole gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: ultrasonic, erythritol, metronidazole gel||
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023853
|PROED, Institute for Professional Education in Dentistry|
|Torino, Italy, 10129|
|Principal Investigator:||Daniele Cardaropoli, DDS||Proed|