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

NCT02023840 | Completed Phase 4

• 1 other identifier: 07.2013.ERYTHRITOL.PROED
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontal Pocket

Keywords

periodontitis; pockets

Outcome Measures

Primary Outcomes (3)

• Probing pocket Depth change

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

  baseline, 6 months

• Bleeding on Probing change

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

  baseline, 6 months

• Clinical Attachment level change

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

  baseline, 6 months

Study Arms (2)

ultrasonics and erythritol, metronidazole gel

ACTIVE COMPARATOR

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

Drug: metronidazole gel; Procedure: ultrasonics; Procedure: erythritol

ultrasonics and erythritol, placebo

PLACEBO COMPARATOR

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

Procedure: ultrasonics; Procedure: erythritol; Drug: placebo

Interventions

metronidazole gel DRUG

ultrasonics and erythritol, metronidazole gel

ultrasonics PROCEDURE

ultrasonics and erythritol, metronidazole gel; ultrasonics and erythritol, placebo

erythritol PROCEDURE

ultrasonics and erythritol, metronidazole gel; ultrasonics and erythritol, placebo

placebo DRUG

ultrasonics and erythritol, placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Heavy smokers current pregnant patients history of malignancy Long term steroidal or antibiotic therapy

Sponsors & Collaborators

• Proed, Torino, Italy: lead

Study Sites (1)

PROED, Institute for Professional Education in Dentistry

Torino, 10129, Italy

Location

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Interventions

High-Energy Shock Waves; Erythritol

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Daniele Cardaropoli, DDS

  Proed, Torino, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)