Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in... | NCT04658225

Studies
Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults

NCT04658225

Sponsor

Universidade Federal Fluminense

Status

Completed

Last Update Posted

Dec 11, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Age Problem

Interventions

0.12% chlorhexidine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Dec 1, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2020

Last Update Posted Date

Dec 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriela Alessandra da Cruz Galhardo Camargo, Clinical Professor, Universidade Federal FluminensePrincipal Investigator

Lead Sponsor

Universidade Federal FluminenseOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Solution 1	Active Comparator	0.12% chlorhexidine	Procedure: 0.12% chlorhexidine
Solution 2	Placebo Comparator	Saline solution	Procedure: 0.12% chlorhexidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Days

Maximum Age

30 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal Fluminense		Nova Friburgo	Rio de Janeiro	28625650	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002710	Chlorhexidine
D000077330	Saline Solution

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000077324

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

Masking

Triple

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.

Who Masked

ParticipantCare ProviderInvestigator