NCT01318928

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

2.7 years

First QC Date

January 4, 2011

Last Update Submit

November 19, 2013

Conditions

Digestive System DisordersAdverse Effects

Keywords

Periodontitisantibioticstreatment periodmicrobiology

Outcome Measures

Primary Outcomes (1)

  • Periodontal Attachment Level

    Measurements on roentgenograms of bone level vs fixed point on teeth

    5 years post-treatment

Secondary Outcomes (1)

  • Microbiological diagnosis

    5 year post-treatment

Study Arms (1)

Periodontal intervention, sugar pill

PLACEBO COMPARATOR

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

Interventions

MetronidazolDRUG

metronidazol. 400mg x 3 per day for 10 days

Also known as: Flagyl 400mg, Novartis
Periodontal intervention, sugar pill

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Signing an informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holtanklinikken, Bø i Telemark

Bø, Telemark, 3500, Norway

Location

Related Publications (5)

  • Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.

    PMID: 34790237DERIVED

  • Preus HR, Al-Lami Q, Baelum V. Oral hygiene revisited. The clinical effect of a prolonged oral hygiene phase prior to periodontal therapy in periodontitis patients. A randomized clinical study. J Clin Periodontol. 2020 Jan;47(1):36-42. doi: 10.1111/jcpe.13207. Epub 2019 Nov 20.

    PMID: 31603245DERIVED

  • Preus HR, Gjermo P, Baelum V. A double-masked Randomized Clinical Trial (RCT) comparing four periodontitis treatment strategies: 5-year clinical results. J Clin Periodontol. 2017 Oct;44(10):1029-1038. doi: 10.1111/jcpe.12793. Epub 2017 Sep 15.

    PMID: 28796888DERIVED

  • Preus HR, Gjermo P, Baelum V. A Randomized Double-Masked Clinical Trial Comparing Four Periodontitis Treatment Strategies: 5-Year Tooth Loss Results. J Periodontol. 2017 Feb;88(2):144-152. doi: 10.1902/jop.2016.160332. Epub 2016 Oct 21.

    PMID: 27767387DERIVED

  • Vatne JF, Gjermo P, Sandvik L, Preus HR. Patients' perception of own efforts versus clinically observed outcomes of non-surgical periodontal therapy in a Norwegian population: an observational study. BMC Oral Health. 2015 May 17;15:61. doi: 10.1186/s12903-015-0037-3.

    PMID: 25981528DERIVED

Related Links

MeSH Terms

Conditions

Digestive System DiseasesPeriodontitis

Interventions

BenchmarkingMetronidazolelactitol

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Management AuditOrganization and AdministrationHealth Services AdministrationProgram EvaluationQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hans R Preus, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, dr.odont

Study Record Dates

First Submitted

January 4, 2011

First Posted

March 21, 2011

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

October 1, 2016

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

NO(1)