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

Periodontal Pocket Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023840
• Other study ID #: 07.2013.ERYTHRITOL.PROED
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: September 1, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Proed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

Drug:
• metronidazole gel

Procedure:
• ultrasonics

• erythritol

Drug:
• placebo

Locations

Country	Name	City	State
Italy	PROED, Institute for Professional Education in Dentistry	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Proed

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket Depth change	Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured	baseline, 6 months	No
Primary	Bleeding on Probing change	Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected	baseline, 6 months	No
Primary	Clinical Attachment level change	Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured	baseline, 6 months	No