search
Back to results

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis

Primary Purpose

Periodontal Pocket

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
metronidazole gel
ultrasonics
erythritol
placebo
Sponsored by
Proed, Torino, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket focused on measuring periodontitis, pockets

Eligibility Criteria

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

Inclusion Criteria:

  • adult patients suffering from periodontitis at least 4 sites with probing pocket depth =>4mm

Exclusion Criteria:

  • Heavy smokers current pregnant patients 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 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ultrasonics and erythritol, metronidazole gel

ultrasonics and erythritol, placebo

Arm Description

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo

Outcomes

Primary Outcome Measures

Probing pocket Depth change
Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured
Bleeding on Probing change
Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected
Clinical Attachment level change
Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured

Secondary Outcome Measures

Full Information

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

1. Study Identification

Unique Protocol Identification Number
NCT02023840
Brief Title
The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis
Official Title
The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Periodontitis: a Split-mouth Randomized Controlled Clinical Trial
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
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets. 20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. 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 Description
The long term results and benefit of infection control in the treatment of periodontal disease have been well documented. According to a cause-related concept, the disruption of bacterial plaque biofilms can be defined as primary objective for the treatment of periodontitis. In the past few years, glycine powder air polishing showed positive outcomes in removing subgingival biofilm in periodontal pockets, and subgingivally delivered metronidazole seemed to improve the results of scaling and root-planing alone . Recently, a new prophylactic powder has been developed. The special action of the powder is attributable to the new ingredient Erythritol and the extra-fine grains that measure only 14 microns. The small size results on one hand in a minimal impact per grain on the treated surface and on the other hand in a very dense jet of powder, efficient on biofilm. Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets. MATERIALS & METHODS: 20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the tip connected to the Handpiece Led for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder applied by the use of Perio-Flow Handpiece with Perio-Flow Nozzle, connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. 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
Periodontal Pocket
Keywords
periodontitis, pockets

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasonics and erythritol, metronidazole gel
Arm Type
Active Comparator
Arm Description
Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel
Arm Title
ultrasonics and erythritol, placebo
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo
Intervention Type
Drug
Intervention Name(s)
metronidazole gel
Intervention Type
Procedure
Intervention Name(s)
ultrasonics
Intervention Type
Procedure
Intervention Name(s)
erythritol
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Probing pocket Depth change
Description
Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured
Time Frame
baseline, 6 months
Title
Bleeding on Probing change
Description
Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected
Time Frame
baseline, 6 months
Title
Clinical Attachment level change
Description
Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured
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 periodontitis at least 4 sites with probing pocket depth =>4mm Exclusion Criteria: Heavy smokers current pregnant patients 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

Plan to Share IPD
No

Learn more about this trial

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis

We'll reach out to this number within 24 hrs