Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

December 9, 2020 updated by: Gabriela Alessandra da Cruz Galhardo Camargo, Universidade Federal Fluminense
The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an anti-inflammatory agent and reducing the presence of biofilm in young adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Nova Friburgo, Rio De Janeiro, Brazil, 28625650
        • Universidade Federal Fluminense

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of gingivitis
  • Probing depth (PD) with maximum 3 mm
  • Minimum of 20 teeth
  • Age between 18 and 30 years old

Exclusion Criteria:

  • Patients with periodontal disease (PD ≥ 4mm with clinical attachment loss)
  • Diabetes
  • Osteoporosis
  • Pregnant or lactating females
  • Smokers
  • Users of immune suppressive medication
  • Phenytoin or cyclosporine
  • Calcium channel blockers
  • Antibiotics
  • Nonsteroidal anti-inflammatory drugs
  • HIV+ or AIDS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Solution 1
0.12% chlorhexidine
Procedure: 0.12% chlorhexidine
the patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
Other Names:
  • Saline Solution
PLACEBO_COMPARATOR: Solution 2
Saline solution
Procedure: 0.12% chlorhexidine
the patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
Other Names:
  • Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 30 days
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index
Time Frame: 30 days
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (ACTUAL)

December 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 69912817.0.0000.5626.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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