Clinical trial NCT02624336: Evaluation of Synergistic Anti-plaque Activity of Salvadora Persica L. and Green Tea: A Clinical Comparative Study
Official title: Evaluation of Synergistic Anti-plaque Activity of Salvadora Persica L. and Green Tea: A Clinical Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: periodontal disease
caries
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 14
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Accumulation of dental plaque may result in negative effects on the tooth and tooth supporting periodontal tissue. In addition, it contributes to the development of caries and periodontal diseases. Therefore, an effective dental plaque control is essential for maintaining good oral hygiene. Mechanical plaque control has its limitation thus chemical plaque control may be used as an adjunct in dental plaque control. Various types of medicinal plants can be utilized as stable, safe and biologically active plant-derived galenicals as alternative to synthetic mouth wash. Among these plants, Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous 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 as a synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers.

Detailed description: Dental plaque is the soft deposits that form the biofilm adhering to the tooth surface or other hard surfaces inside oral cavity, including removable and fixed restoration. The dental plaque is composed of over 500 bacterial species. The colonization of these bacteria follows a special pattern starting by adhesion of initial bacterial colonizers to the salivary pellicles covering tooth enamel and other hard surfaces in the oral cavity followed by secondary colonization of follower bacteria through inter-bacterial adhesion leading to dental plaque maturation.

Periodontal health can be considered to be in a state of balance when the bacterial mass presents in the host oral cavity and causes no damage to either the bacteria or the host periodontal tissues. Any disruption of this balance results in alterations in both the host periodontal and biofilm bacteria and leads ultimately to destruction of the periodontium. Accumulation of dental plaque may lead to several harmful effects on the tooth and tooth supporting periodontal tissue that contributes to the development of caries and periodontal diseases. Therefore, an effective dental plaque control is essential for maintaining good oral hygiene.

Mechanical plaque control, by using toothbrushes and interdental aids, is the mostly adopted method. Unfortunately, it is a time consuming process and needs high manual dexterity. Moreover, epidemiological studies revealed high prevalence of gingivitis among toothbrush users. Hence, chemical plaque control may be used to assist in dental plaque control.

The anti-plaque agent is that agent that interferes with one of the different phases of dental plaque development: interferes with the adhesion of oral bacteria to oral surfaces and prevent biofilm formation; interferes with co-aggregation mechanism which thereby prevents future growth of micro-colonies; or removes or disrupts existing dental plaque. To date, chlorhexidine (CHX) mouthwash is the standard solution used in chemical plaque control, but it was found to have several side effects including tooth and some restorations staining, unpleasant test, sloughing of oral mucosa and enhancement of supra-gingival calculus formation.

The widely available traditional natural medicinal plants can be utilized as stable, safe and biologically active plant-derived galenicals as alternative to synthetic drugs. Among these plants, Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis. Kuntze, aqueous extracts were reported to have anti-microbial activity against many oral bacteria. In our in vitro study, we found that the combination (Co.) of 0.25mg Gt aqueous extract and 7.82mg Sp aqueous extract in 1ml exhibited significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers.

The dental plaque is classified into two categories, supra-gingival plaque and sub-gingival plaque, in relation to gingival margin. The supra-gingival dental plaque may be readily visualized on teeth after 24 to 48 hours with no oral hygiene measures and it appears white, grayish, or yellow in color and has a globular appearance.

Supra-gingival plaque accumulation on tooth surfaces can be quantified through different plaque index systems. In this study, the clinical parameter to record plaque quantity was modified Quigely Hein Plaque Index. In this index, a score of 0 to 5 was assigned for each facial and lingual (palatal) surface of all teeth except the third molars.

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 DTC1 and placebo comparators i.e. Oradex and distilled water, as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified Quigely Hein Plaque Index [Turesky, 1970].
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: Nor_Adinar Baharuddin, DClinDent
role: PRINCIPAL_INVESTIGATOR
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