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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
Proed, Torino, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis and Peri-implant Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 18, 2013
Last Updated
September 1, 2016
Sponsor
Proed, Torino, Italy
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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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