The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis
NCT ID: NCT02023840
Last Updated: 2016-09-02
Study Results
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Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ultrasonics and erythritol, metronidazole gel
Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel
metronidazole gel
ultrasonics
erythritol
ultrasonics and erythritol, placebo
Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo
ultrasonics
erythritol
placebo
Interventions
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metronidazole gel
ultrasonics
erythritol
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Proed, Torino, Italy
OTHER
Responsible Party
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Principal Investigators
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Daniele Cardaropoli, DDS
Role: PRINCIPAL_INVESTIGATOR
Proed, Torino, Italy
Locations
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PROED, Institute for Professional Education in Dentistry
Torino, , Italy
Countries
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Other Identifiers
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07.2013.ERYTHRITOL.PROED
Identifier Type: -
Identifier Source: org_study_id
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