Clinical trial NCT03790904: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Diseases
Keywords: Dental plaque,
Tea
Salvadora
Mouthwash
Clinical trial
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Mean amount plaque between different comparators
timeFrame: Time Frame: 24 hours
measure: Mean amount plaque between different comparators
timeFrame: Time Frame: 4 days
Secondary outcomes:
measure: Mean bacterial load in saliva
timeFrame: 2 hours
measure: Mean relative changes in gingival crevicular fluid flow rate
timeFrame: 4 days
measure: Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
timeFrame: 4 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Hayder R Abdulbaqi
Study officials:
affiliation: University of Baghdad
name: Rasha S Abbood
role: PRINCIPAL_INVESTIGATOR
References: