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

Periodontal Pocket research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Periodontal Pocket

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:metronidazole gel

Procedure:ultrasonics

Procedure:erythritol

Drug:placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: December 2013

Completed Date: December 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Probing pocket Depth change

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Daniele Cardaropoli, DDS

Lead Sponsor: Proed

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02023840

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