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

• ClinicalTrials.gov Identifier: NCT03790904
• Recruitment Status: Completed
• First Posted: January 2, 2019
• Last Update Posted: May 14, 2019
• Sponsor: University of Baghdad
• Information provided by (Responsible Party): Hayder Raad Abdulbaqi, University of Baghdad

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.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases	Other: Co.; Other: Kin; Other: Distilled water	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: March 31, 2019
• Actual Study Completion Date: April 9, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Co. mouthwash; 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min	Other: Co.; 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	Other: Kin; 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	Other: Distilled water; 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 23 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Iraq

Hayder R Abdulbaqi

Baghdad, Iraq, 10011

Sponsors and Collaborators

University of Baghdad

Investigators

• Principal Investigator: Rasha S Abbood; University of Baghdad

More Information

• Responsible Party: Hayder Raad Abdulbaqi, Principal Investigator, University of Baghdad
• ClinicalTrials.gov Identifier: NCT03790904
• Other Study ID Numbers: 011618
• First Posted: January 2, 2019
• Last Update Posted: May 14, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hayder Raad Abdulbaqi, University of Baghdad:

Dental plaque,; Tea; Salvadora; Mouthwash; Clinical trial

Additional relevant MeSH terms:

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases