Non Surgical Treatment of Periimplantitis

NCT02023853 | Completed Phase 4

• 1 other identifier: Proed.08.2013.periimplantitis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included. Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. 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

Peri-Implantitis and Peri-implant Mucositis

Outcome Measures

Primary Outcomes (3)

• probing pocket depth change

  baseline, 6 months

• bleeding on probing change

  baseline, 6 months

• clinical attachment level change

  baseline, 6 months

Study Arms (1)

ultrasonic, erythritol, metronidazole gel

EXPERIMENTAL

Procedure: ultrasonic; Procedure: erythritol; Drug: metronidazole gel

Interventions

ultrasonic PROCEDURE

ultrasonic, erythritol, metronidazole gel

erythritol PROCEDURE

ultrasonic, erythritol, metronidazole gel

metronidazole gel DRUG

ultrasonic, erythritol, metronidazole gel

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 peri-implant mucositis or peri-implantitis

You may not qualify if:

• Heavy smokers current pregnant 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

Peri-Implantitis

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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

Locations

IT (1)