We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Treatment of Periodontal Diseases

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: NCT01318928
Recruitment Status : Unknown
Verified November 2013 by Hans Ragnar Preus, University of Oslo.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2011
Last Update Posted : November 20, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to examine if the correct use of antibiotics, as well as the application of one-day-treatment, in the therapy of periodontal diseases. The population of treated patients (184) are divided in 4 groups; Group 1: Metronidazole + mechanical treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3: Metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21 End points, BOP, Plaque, PPD, CAL, RAL, Microbiology will be recorded on all sites at 3 months, 1 -, 3 -, and 5 years post-treatment

Condition or disease Intervention/treatment Phase
Digestive System Disorders Adverse Effects Drug: Metronidazol Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Periodontal Diseases. A Randomized, Blinded, Five Years Follow-up, Four-arm, Placebo Controlled Clinical Intervention Trial
Study Start Date : January 2008
Primary Completion Date : September 2010
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Periodontal intervention, sugar pill
Group 1: metronidazole + mechanical treatment in one day, Group 2: Placebo + mechanical treatment in one day Group 3: metronidazole + mechanical treatment on day 1 and 21 Group 4: Placebo + mechanical treatment on day 1 and 21
Drug: Metronidazol
metronidazol. 400mg x 3 per day for 10 days
Other Name: Flagyl 400mg, Novartis


Outcome Measures

Primary Outcome Measures :
  1. Periodontal Attachment Level [ Time Frame: 5 years post-treatment ]
    Measurements on roentgenograms of bone level vs fixed point on teeth


Secondary Outcome Measures :
  1. Microbiological diagnosis [ Time Frame: 5 year post-treatment ]
    Microbiological diagnosis is performed in 2 different labs and with two different techniques at 3 months, 1 year, 3 year and 5 year post-treatment. Negative and positive controls are being applied and all microbiological diagnosis from baseline, 3 and 12 months are run twice, with second run blinded


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females and males with advanced periodontal disease referred between November 2007 and January 2009.
  • No diseases known to be associated with periodontal diseases, i.e. diabetes mellitus, rheumatoid arthritis, pregnancies.
  • No continuous medication known to affect the severity or progression of periodontal diseases.
  • No previous systematic periodontal treatment.
  • More than 5 pockets 5mm < PPD < 9 mm after a 3 month hygiene phase - i.e. before inclusion into study.
  • Oral hygiene; < 5% of surfaces with plaque at inclusion time.
  • Signing an informed consent.

Exclusion criteria:

  • diseases known to be associated with periodontal diseases, i.e. diabetes mellitus, rheumatoid arthritis.
  • pregnancy
  • continuous medication known to affect the clinical expression of periodontal diseases
  • subgingival microbiological diagnosis which reveals bacteria with reduced/no sensitivity to metronidazole
Contacts and Locations

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): NCT01318928


Locations
Norway
Holtanklinikken, Bø i Telemark
Bø, Telemark, Norway, 3500
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
Investigators
Principal Investigator: Hans R Preus, PhD University of Oslo
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans Ragnar Preus, professor, dr.odont, University of Oslo
ClinicalTrials.gov Identifier: NCT01318928     History of Changes
Other Study ID Numbers: UiO/IKO/PERIO-1
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Hans Ragnar Preus, University of Oslo:
Periodontitis
antibiotics
treatment period
microbiology

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Digestive System Diseases
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents