Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

NCT04658225 | Completed DMC

• 1 other identifier: CAAE: 69912817.0.0000.5626.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Problem

Keywords

Gingivitis; Periodontal treatment

Outcome Measures

Primary Outcomes (1)

• Plaque Index

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

  30 days

Secondary Outcomes (1)

• Gingival Index

  30 days

Study Arms (2)

Solution 1

ACTIVE COMPARATOR

0.12% chlorhexidine

Procedure: 0.12% chlorhexidine

Solution 2

PLACEBO COMPARATOR

Saline solution

Procedure: 0.12% chlorhexidine

Interventions

0.12% chlorhexidine 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.

Also known as: Saline Solution

Solution 1; Solution 2

Eligibility Criteria

• Age: 30 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Chlorhexidine; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: August 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)