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Non Surgical Treatment of Periimplantitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02023853
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Proed

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).


Condition or disease Intervention/treatment Phase
Peri-Implantitis and Peri-implant Mucositis Procedure: ultrasonic Procedure: erythritol Drug: metronidazole gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ultrasonic, erythritol, metronidazole gel Procedure: ultrasonic
Procedure: erythritol
Drug: metronidazole gel



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023853


Locations
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Italy
PROED, Institute for Professional Education in Dentistry
Torino, Italy, 10129
Sponsors and Collaborators
Proed
Investigators
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Principal Investigator: Daniele Cardaropoli, DDS Proed
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Responsible Party: Proed
ClinicalTrials.gov Identifier: NCT02023853    
Other Study ID Numbers: Proed.08.2013.periimplantitis
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Mucositis
Peri-Implantitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases
Metronidazole
Erythritol
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Vasodilator Agents