- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023853
Non Surgical Treatment of Periimplantitis
The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Torino, Italy, 10129
- PROED, Institute for Professional Education in Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients suffering from peri-implant mucositis or peri-implantitis
Exclusion Criteria:
- Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ultrasonic, erythritol, metronidazole gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
probing pocket depth change
Time Frame: baseline, 6 months
|
baseline, 6 months
|
bleeding on probing change
Time Frame: baseline, 6 months
|
baseline, 6 months
|
clinical attachment level change
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniele Cardaropoli, DDS, Proed, Torino, Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Proed.08.2013.periimplantitis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peri-Implantitis and Peri-implant Mucositis
-
University of ZagrebNot yet recruitingPeri-implant Mucositis | Peri-Implantitis and Peri-implant Mucositis | Peri-implant Health | Periimplant Diseases | Periimplant Bone Loss
-
Tuğba ŞAHİNCompletedPeri-Implantitis, Peri-implant MucositisTurkey
-
Ramón Pons CalabuigRecruitingPeri-Implantitis | Peri-implant Mucositis | Peri-implant HealthSpain
-
Simón Pardiñas LópezGöteborg University; NYU Langone Health; University Hospital A Coruña; Instituto...Active, not recruitingImplant Tissue Failure | Peri-Implantitis | Peri-implant Mucositis | Implant ComplicationSpain
-
University of PaviaNot yet recruitingPeri-Implantitis | Peri-implant Mucositis | Dental Implant FailedItaly
-
University of MilanRecruitingPeri-Implantitis | Peri-implant Mucositis | Dental Implant FailedItaly
-
Berceste GulerCompletedPeri-Implantitis | Peri-implant Mucositis | Dental Implant FailedTurkey
-
University of OsloRecruiting
-
Alanya Alaaddin Keykubat UniversityCompletedPeri-Implantitis | Peri-implant Mucositis
-
Universidad Complutense de MadridEklund Foundation; SEPA (Sociedad Española de Periodoncia)RecruitingPeri-Implantitis | Peri-implant MucositisSpain
Clinical Trials on ultrasonic
-
Brock UniversityDr. Peter C. Fritz, Periodontal Wellness & Implant SurgeryCompletedPeriodontitis | Periodontal PocketCanada
-
Universidad de GranadaCompleted
-
Second Affiliated Hospital, School of Medicine,...Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; First Affiliated Hospital of Wenzhou Medical UniversityUnknownRenal Insufficiency | Renal TransplantationChina
-
Tianjin Third Central HospitalBGI, ChinaRecruitingHepatocellular CarcinomaChina
-
University of OsloRecruiting
-
Second Affiliated Hospital, School of Medicine,...Completed
-
Cukurova UniversityCompleted
-
Vejle HospitalCompleted
-
Ethicon Endo-SurgeryChildren's Hospital Medical Center, CincinnatiTerminated
-
ZetrOZ, Inc.State University of New York - Upstate Medical UniversityTerminated