NCT01213550

Brief Summary

The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

Status
completed

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

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

1.8 years

First QC Date

October 1, 2010

Last Update Submit

October 1, 2010

Conditions

This Study Evaluated the Effectiveness of Chlorhexidine Mouthrinse on Subgingival Microbiota

Outcome Measures

Primary Outcomes (2)

  • effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control

  • effectiveness of chlorhexidine mouthrinse subgingival microbiota in addition to daily mechanical plaque control

Study Arms (2)

Chlorhexidine

EXPERIMENTAL
Drug: Chlorhexidine gluconate

Placebo mouthrinse

PLACEBO COMPARATOR
Drug: Placebo mouthrinse

Interventions

Chlorhexidine gluconateDRUG
Chlorhexidine
Placebo mouthrinseDRUG
Placebo mouthrinse

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • years old male or female with gingivitis associated with dental plaque, no clinical signs of destructive periodontal disease, clinical attachment loss \< 3mm, a minimum of 20 teeth (teeth that have gross caries, were fully crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count).

You may not qualify if:

  • use of tobacco products, history or current manifestation of systemic disease which could impair immune response such as diabetes mellitus, immunological disorders, hepatitis and HIV infections, use of antibiotic or anti-inflammatory or immunosuppressive drugs during 3 months period prior to the start of the trial, periodontal therapy during the last 3 month, pregnancy or lactation and oral contraceptives usage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ege U School of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Ege University School of Dentistry Dep of Periodontology

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (1)

  • Turkoglu O, Becerik S, Emingil G, Kutukculer N, Baylas H, Atilla G. The effect of adjunctive chlorhexidine mouthrinse on clinical parameters and gingival crevicular fluid cytokine levels in untreated plaque-associated gingivitis. Inflamm Res. 2009 May;58(5):277-83. doi: 10.1007/s00011-008-8129-z.

    PMID: 19184351RESULT

MeSH Terms

Interventions

chlorhexidine gluconate

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

TU(2)