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OpenTrials
Completed

NCT Number: NCT02023853

Non Surgical Treatment of Periimplantitis

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).

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Key information

Conditions

Peri-Implantitis and Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PROED, Institute for Professional Education in Dentistry

Torino, 10129, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients suffering from peri-implant mucositis or peri-implantitis

Exclusion criteria

  • Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy

Treatment and study plan

ultrasonic

Procedure

erythritol

Procedure

Metronidazole gel

Drug

Primary outcomes

  1. probing pocket depth change

    Time frame: baseline, 6 months

  2. bleeding on probing change

    Time frame: baseline, 6 months

  3. clinical attachment level change

    Time frame: baseline, 6 months

Sponsors and collaborators

Lead sponsor

Proed, Torino, Italy

Other

Registry information

Official study title

The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2013
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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