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Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

NCT ID: NCT04658225

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Age Problem

Keywords

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Gingivitis Periodontal treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Solution 1

0.12% chlorhexidine

Group Type ACTIVE_COMPARATOR

0.12% chlorhexidine

Intervention Type PROCEDURE

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.

Solution 2

Saline solution

Group Type PLACEBO_COMPARATOR

0.12% chlorhexidine

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Saline Solution

Eligibility Criteria

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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
Minimum Eligible Age

30 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal Fluminense

OTHER

Sponsor Role lead

Responsible Party

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Gabriela Alessandra da Cruz Galhardo Camargo

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE: 69912817.0.0000.5626.

Identifier Type: -

Identifier Source: org_study_id