Non Surgical Treatment of Periimplantitis
Primary Purpose
Peri-Implantitis and Peri-implant Mucositis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ultrasonic
erythritol
metronidazole gel
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis and Peri-implant Mucositis
Eligibility Criteria
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
Sites / Locations
- PROED, Institute for Professional Education in Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ultrasonic, erythritol, metronidazole gel
Arm Description
Outcomes
Primary Outcome Measures
probing pocket depth change
bleeding on probing change
clinical attachment level change
Secondary Outcome Measures
Full Information
NCT ID
NCT02023853
First Posted
December 18, 2013
Last Updated
September 1, 2016
Sponsor
Proed, Torino, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02023853
Brief Title
Non Surgical Treatment of Periimplantitis
Official Title
The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proed, Torino, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis and Peri-implant Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasonic, erythritol, metronidazole gel
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
ultrasonic
Intervention Type
Procedure
Intervention Name(s)
erythritol
Intervention Type
Drug
Intervention Name(s)
metronidazole gel
Primary Outcome Measure Information:
Title
probing pocket depth change
Time Frame
baseline, 6 months
Title
bleeding on probing change
Time Frame
baseline, 6 months
Title
clinical attachment level change
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Cardaropoli, DDS
Organizational Affiliation
Proed, Torino, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
PROED, Institute for Professional Education in Dentistry
City
Torino
ZIP/Postal Code
10129
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Non Surgical Treatment of Periimplantitis
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