Evaluation of Synergistic Anti-plaque Activity of Salvadora Persica L. and Green Tea: A Clinical Comparative Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): DTC1; Oradex; Distilled water
Intervention type(s): Other; Other; Other
Intervention description(s): 15ml DTC1 twice a day, rinse for 30sec refrain from eating or drinking for 30min; 15ml Chlorhexidine gluconate 0.12% (w/v) twice a day, rinse for 30sec refrain from eating or drinking for 30min; 15ml distilled water twice a day, rinse for 30sec refrain from eating or drinking for 30min
Other intervention name(s): CHX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: periodontal disease; caries