The Efficacy of OrasaltsTM in the Treatment of Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Gingivitis is defined as inflammation of the gingiva. It is a common disease that is
      prevalent in both children and adults, and in both genders . The primary cause of gingivitis
      is plaque accumulation due to poor oral hygiene; however, gingivitis may result from many
      varied aetiological factors. Gingivitis is characterized by red, swollen, spongy gums that
      bleed easily . Current conventional treatment of gingivitis involves removal of plaque and
      the use of an antimicrobial mouthwash. Mouthwashes containing chlorhexidine gluconate are
      most commonly prescribed, however these have certain adverse effects. Ora-saltsTM is a
      commercially available mouthwash composed of natural sea salt, Arnica montana 30 centesimal
      (C), Echinacea angustifolia 30C, Staphisagria 30C, Phosphorus 30C, Hepar sulph 30C, cinnamon
      and liquorice. To date there is no research on the use of OrasaltsTM in the treatment of
      gingivitis. The aim of this study is to determine the efficacy of OrasaltsTM in the treatment
      of gingivitis using the Modified Gingival Index (MGI) and the Quantitative Gingival Bleeding
      Index (QGBI).
    

Detailed description: 
      The research will involve a randomised, double blind, controlled, 8 day study, using matched
      pairs. The study will take place at the Homoeopathy Health Centre at the University of
      Johannesburg. The research sample will consist of 40 participants aged between 18 to 70 years
      who have gingivitis; recruited by means of an advertisement placed at the University of
      Johannesburg and at a private dental practice with relevant permission given. On day 0 of the
      study potential participants will be requested to sign the Participant Information and
      Consent Form, and will be screened using a Screening Questionnaire to evaluate if they meet
      the inclusion criteria. Those participants who qualify will be invited to participate in the
      study. The researcher will perform the first clinical assessment on each participant on day
      0, using the Modified Gingival Index (MGI) and vital signs will be recorded. Participants
      will be supplied with one container of 120g containing either OrasaltsTM or the control,
      consisting of natural unmedicated sea salt. The participants will be supplied with the
      Quantitative Gingival Bleeding Index (QGBI); they will be requested to complete it on days 1
      to 7 of the study, grading the response of their gingivitis throughout the study. They will
      be requested to use the supplied mouthwash twice a day for 7 days. Participants will be
      supplied with a leaflet informing them how to use the mouthwash and on the practice of good
      oral hygiene. Participants will be asked to return on day 8 of the study, where they will
      return with the completed QGBI form grading the response of their gingivitis. And a second
      assessment using the MGI will be performed by the researcher, and vital signs will be
      recorded. Data obtained will be statistically analysed by means of essential data assessment
      which will determine whether parametric or non-parametric tests will be utilised. A possible
      outcome of this study is to demonstrate that OrasaltsTM may be effective in the treatment of
      gingivitis, providing an alternative treatment option for this condition. This will open up
      the field for further research.
    

Intervention name(s): OrasaltsTM; Sea salt
Intervention type(s): Other; Other
Intervention description(s): OrasaltsTM mouthwash is composed of 119.5g of natural sea salt, Arnica montana 30C, Echinacea angustifolia 30C, Staphysagria 30C, Phosphorus 30C, Hepar sulphuris 30C, 0.27g cinnamon and 0.27g of liquorice; Unmedicated sea salt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment