Non Surgical Treatment of Periimplantitis

Peri-Implantitis and Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023853
• Other study ID #: Proed.08.2013.periimplantitis
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: September 1, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Proed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis
• Peri-Implantitis
• Peri-Implantitis and Peri-implant Mucositis

Intervention

Procedure:
• ultrasonic

• erythritol

Drug:
• metronidazole gel

Locations

Country	Name	City	State
Italy	PROED, Institute for Professional Education in Dentistry	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Proed

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing pocket depth change		baseline, 6 months	No
Primary	bleeding on probing change		baseline, 6 months	No
Primary	clinical attachment level change		baseline, 6 months	No