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Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

Primary Purpose

Age Problem

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
0.12% chlorhexidine
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Problem focused on measuring Gingivitis, Periodontal treatment

Eligibility Criteria

30 Days - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal Fluminense

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Solution 1

Solution 2

Arm Description

0.12% chlorhexidine

Saline solution

Outcomes

Primary Outcome Measures

Plaque Index
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.

Secondary Outcome Measures

Gingival Index
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.

Full Information

First Posted
December 1, 2020
Last Updated
December 9, 2020
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT04658225
Brief Title
Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
Official Title
Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Problem
Keywords
Gingivitis, Periodontal treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Thirty patients with gingivitis ages18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will select and evaluate at baseline and after 4 weeks. The periodontal clinical parameters will verify: plaque index (PI), gingival index (GI) and Simplified Oral Hygiene Index (OHIS). After evaluation of the clinical parameters, the patients will 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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participant will receiver mouthwash solution with labeled number, they will not know which solution will inside. Care provider - The research that will collect clinical parameter wil be different for researcher that will do the treatment. Investigator will not have contact with treatment.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solution 1
Arm Type
Active Comparator
Arm Description
0.12% chlorhexidine
Arm Title
Solution 2
Arm Type
Placebo Comparator
Arm Description
Saline solution
Intervention Type
Procedure
Intervention Name(s)
0.12% chlorhexidine
Other Intervention Name(s)
Saline Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque Index
Description
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Gingival Index
Description
Check the biofilm as Ainano & Bay 1975 index, Higher levels means worse.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidade Federal Fluminense
City
Nova Friburgo
State/Province
Rio De Janeiro
ZIP/Postal Code
28625650
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

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