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Completed

NCT Number: NCT02023840

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PROED, Institute for Professional Education in Dentistry

Torino, 10129, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole gel

Drug

ultrasonics

Procedure

erythritol

Procedure

Placebo

Drug

Primary outcomes

  1. Probing pocket Depth change

    Time frame: baseline, 6 months

    Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured

  2. Bleeding on Probing change

    Time frame: baseline, 6 months

    Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected

  3. Clinical Attachment level change

    Time frame: baseline, 6 months

    Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured

Sponsors and collaborators

Lead sponsor

Proed, Torino, Italy

Other

Registry information

Official study title

The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Periodontitis: a Split-mouth Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2013
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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