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Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Co.
Kin
Distilled water
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases focused on measuring Dental plaque,, Tea, Salvadora, Mouthwash, Clinical trial

Eligibility Criteria

20 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants should be medically healthy.
  • Participants should have more than 20 teeth.

Exclusion Criteria:

  • Participants who have active cavity caries and/or periodontal disease.
  • Participants who have ongoing orthodontic treatment.
  • Participants who have been on antibiotics within the past 4 months.
  • Participants who require prophylactic antibiotic coverage.
  • Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months.
  • Participants who are pregnant or intended to and lactating mother.
  • Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
  • Participants who have any systemic disease.

Sites / Locations

  • Hayder R Abdulbaqi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Co. mouthwash

Kin mouthwash

Distilled water

Arm Description

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

Outcomes

Primary Outcome Measures

Mean amount plaque between different comparators
Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Mean amount plaque between different comparators
Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.

Secondary Outcome Measures

Mean bacterial load in saliva
Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).
Mean relative changes in gingival crevicular fluid flow rate
Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.

Full Information

First Posted
December 28, 2018
Last Updated
May 11, 2019
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT03790904
Brief Title
Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash
Official Title
Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

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

5. Study Description

Brief Summary
Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Mechanical plaque control is important but has limitations; therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours. Moreover, these extracts were reported to have anti-microbial activity against many oral bacteria. The objective of this study was to investigate the efficacy of the combination of Gt aqueous extract and Sp aqueous extract in reducing plaque buildup for 4 days duration.
Detailed Description
Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed of many species of which are commensal and other are pathogenic. The buildup of dental plaque starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature dental plaque. The mature dental plaque initiates host immune response by its bacterial content or its toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of balance when the host immune response resolves the bacterial challenges. In other scenario, the host immune response fails to overcome invader bacteria or their toxins leading to chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be developed due to imbalance between dental plaque accumulation and host defense. For that reason, dental plaque control is essential as preventive measure for good oral health. Mechanical plaque control including tooth brushing and interdental aids is essential for preserving oral health. However, efficient mechanical control is time consuming and needs high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the best-known mouthwash serving that purpose despite its side effects including tooth discoloration and bitter taste. Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous extracts were reported to exert anti-microbial activity against many oral bacteria. A combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo for a period of 24 hours (NCT02624336 in December 3, 2015).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Dental plaque,, Tea, Salvadora, Mouthwash, Clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Co. mouthwash
Arm Type
Active Comparator
Arm Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Arm Title
Kin mouthwash
Arm Type
Placebo Comparator
Arm Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Arm Title
Distilled water
Arm Type
Placebo Comparator
Arm Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Intervention Type
Other
Intervention Name(s)
Co.
Intervention Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Intervention Type
Other
Intervention Name(s)
Kin
Intervention Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Primary Outcome Measure Information:
Title
Mean amount plaque between different comparators
Description
Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Time Frame
Time Frame: 24 hours
Title
Mean amount plaque between different comparators
Description
Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
Time Frame
Time Frame: 4 days
Secondary Outcome Measure Information:
Title
Mean bacterial load in saliva
Description
Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).
Time Frame
2 hours
Title
Mean relative changes in gingival crevicular fluid flow rate
Description
Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.
Time Frame
4 days
Title
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
Description
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants should be medically healthy. Participants should have more than 20 teeth. Exclusion Criteria: Participants who have active cavity caries and/or periodontal disease. Participants who have ongoing orthodontic treatment. Participants who have been on antibiotics within the past 4 months. Participants who require prophylactic antibiotic coverage. Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months. Participants who are pregnant or intended to and lactating mother. Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses. Participants who have any systemic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha S Abbood
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hayder R Abdulbaqi
City
Baghdad
ZIP/Postal Code
10011
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash

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