Non Surgical Treatment of Periimplantitis

NCT ID: NCT02023853

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Peri-Implantitis and Peri-implant Mucositis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasonic, erythritol, metronidazole gel

Group Type EXPERIMENTAL

ultrasonic

Intervention Type PROCEDURE

erythritol

Intervention Type PROCEDURE

metronidazole gel

Intervention Type DRUG

Interventions

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ultrasonic

Intervention Type PROCEDURE

erythritol

Intervention Type PROCEDURE

metronidazole gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proed, Torino, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniele Cardaropoli, DDS

Role: PRINCIPAL_INVESTIGATOR

Proed, Torino, Italy

Locations

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PROED, Institute for Professional Education in Dentistry

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Proed.08.2013.periimplantitis

Identifier Type: -

Identifier Source: org_study_id

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