Green Tea Mouthwash on Generalized Plaque- Induced Gingiv... | NCT04484792

Studies
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis

NCT04484792

Sponsor

Taibah University

Status

Completed

Last Update Posted

Jul 24, 2020Actual

Enrollment

45Actual

Phase

Phase 3

Conditions

Plaque Induced Gingivitis

Interventions

green tea mouthwash
green tea mouthwash
placebo

Countries

Saudi Arabia

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

Jul 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

Nov 27, 2018Actual

Primary Completion Date

Mar 27, 2020Actual

Completion Date

Apr 20, 2020Actual

First Submitted Date

Jul 21, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 24, 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

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group A	Experimental	Other: green tea mouthwash
Group B	Experimental	Other: green tea mouthwash
Group C	Placebo Comparator	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
green tea mouthwash	Other	green tea bags in 100 ml warm water for 5 min	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plaque control record		over 27 days
gingival bleeding index		over 27 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)
Age from 18 - 35 years
Generalized plaque-induced gingivitis (GBI > 85%)

Exclusion Criteria:

Patients with any systemic diseases
Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)
Pregnant or breast-feeding patients
Smokers
Periodontitis patients
Patients who received any form of periodontal therapy within the last 6 months
Patients who were under antibiotic therapy the past month
Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

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
Taibah University		Al Madīnah			Saudi Arabia