Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Co.; Kin; Distilled water
Intervention type(s): Other; Other; Other
Intervention description(s): 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; 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental plaque,; Tea; Salvadora; Mouthwash; Clinical trial