- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790904
Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash
Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Baghdad, Iraq, 10011
- Hayder R Abdulbaqi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Co. mouthwash
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
|
Placebo Comparator: Kin mouthwash
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
|
Placebo Comparator: Distilled water
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean amount plaque between different comparators
Time Frame: Time Frame: 24 hours
|
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: 24 hours
|
Mean amount plaque between different comparators
Time Frame: Time Frame: 4 days
|
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: 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean bacterial load in saliva
Time Frame: 2 hours
|
Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).
|
2 hours
|
Mean relative changes in gingival crevicular fluid flow rate
Time Frame: 4 days
|
Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.
|
4 days
|
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
Time Frame: 4 days
|
Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rasha S Abbood, University of Baghdad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Diseases
-
G. d'Annunzio UniversityNot yet recruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, Periodontal
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
-
British University In EgyptRecruitingPeriodontal Diseases | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationEgypt
-
Technische Universität DresdenCompletedPeriodontal Disease | Periodontal Attachment LossGermany
-
Universidad de MurciaCompletedPeriodontitis | Periodontal Diseases | Periodontal Pocket | Periodontal Attachment LossSpain
-
Brock UniversityDr. Peter C. Fritz, Periodontal Wellness & Implant SurgeryCompletedPeriodontal Pocket | Periodontal Attachment LossCanada
-
Texas A&M UniversityInstitut Straumann AGRecruitingPeriodontitis | Attachment Loss, PeriodontalUnited States
-
University of FlorenceRecruitingPeriodontitis | Periodontal Pocket | Periodontal Attachment LossItaly
-
Brock UniversityDr. Peter C. Fritz, Periodontal Wellness & Implant SurgeryCompleted
-
Wuerzburg University HospitalUnknownPeriodontitis | Periodontal Attachment Loss | Periodontal; LesionGermany
Clinical Trials on Co.
-
Haukeland University HospitalCompleted
-
Boston Medical CenterNot yet recruitingSubstance Use Disorders | Mental Health IssueUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)Active, not recruitingQuality of Life | Multimorbidity | Symptom ManagementUnited States
-
Federal University of Minas GeraisCompletedAttention Deficit and Disruptive Behavior Disorders | Motor Skills DisordersBrazil
-
Memorial Sloan Kettering Cancer CenterTerminated
-
PXL University CollegeRecruitingExercise | Older Adults | Mobile ApplicationBelgium
-
IpasTerminatedAbortion, Induced | Abortion, IncompleteMexico, South Africa
-
Children's Hospital of PhiladelphiaChildren's Anesthesiology Associates, Ltd.CompletedScoliosis | Spinal FusionUnited States
-
University of RochesterRecruiting
-
George Papanicolaou HospitalNot yet recruitingCoronary Artery Disease | Aortic Valve Disease | Mitral Valve Disease