Non Surgical Treatment of Periimplantitis

Phase 4

Completed

• Conditions: Peri-Implantitis and Peri-implant Mucositis
• Interventions: Procedure: ultrasonic; Procedure: erythritol; Drug: metronidazole gel

• Registration Number: NCT02023853
• Lead Sponsor: Proed, Torino, Italy

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-30
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasonic, erythritol, metronidazole gel	ultrasonic	-
ultrasonic, erythritol, metronidazole gel	erythritol	-
ultrasonic, erythritol, metronidazole gel	metronidazole gel	-

Primary Outcome Measures

Name	Time	Method
probing pocket depth change	baseline, 6 months
bleeding on probing change	baseline, 6 months
clinical attachment level change	baseline, 6 months

Trial Locations

Locations (1)

PROED, Institute for Professional Education in Dentistry; 🇮🇹 Torino, Italy