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The Efficacy of OrasaltsTM in the Treatment of Gingivitis

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ClinicalTrials.gov Identifier: NCT02168335
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Dr J. Pellow, University of Johannesburg

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Modified Gingival Index (MGI) [ Time Frame: 8 days ]
MGI is a non-invasive method, used by the researcher, to assess inflammation of the gingiva in all 40 participants, at each consultation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Quantitative Gingival Bleeding Index (QGBI) [ Time Frame: 8 days ]
QGBI will be used by the participants to rate gingival bleeding on a daily basis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of OrasaltsTM in the Treatment of Gingivitis
Official Title  ICMJE The Efficacy of OrasaltsTM in the Treatment of Gingivitis
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • Other: OrasaltsTM
    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
  • Other: Sea salt
    Unmedicated sea salt
Study Arms  ICMJE
  • Experimental: Treatment group

    OrasaltsTM

    1 level scoop of OrasaltsTM will be dissolved in warm water. Participants will rinse and gargle the mouth for 30 seconds, then expel and not swallow the mixture, twice daily

    Intervention: Other: OrasaltsTM
  • Placebo Comparator: Control group

    Sea salt

    1 level scoop of sea salt will be dissolved in warm water. Participants will rinse and gargle the mouth for 30 seconds, then expel and not swallow the mixture, twice daily

    Intervention: Other: Sea salt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are between the ages of 18 and 70; and
  • Have active gingivitis at the time of the study including at least 3 of the following symptoms: red, swollen, and spongy gums; gums that bleed spontaneously or after brushing, eating or touching of the gums; having bad breath; sensation of tingling or itching of the gums; and the presence of pus in the pockets between teeth

Exclusion Criteria:

  • • Present with any relevant systemic diseases which are known to cause gingivitis such as conditions affecting the immune system, including autoimmune conditions (Sjögrens syndrome, rheumatoid arthritis, systemic lupus erythematosus, diabetes mellitus etc.) and immune deficiencies such as HIV and AIDS, mental health diseases (such as anxiety or depression), malignancy, thyroid conditions, xerostomia, nutritional deficiencies and uncontrolled hypertension

    • Are taking antibiotics or anti-inflammatory drugs during or for 1 month prior to the study onset
    • Have a known allergy to cinnamon or liquorice; and/or
    • Are taking Warfarin or other blood thinning medication Participants will be requested not to make use of any other medication/mouthwashes to treat their gingivitis for the duration of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168335
Other Study ID Numbers  ICMJE DaSilva200814363
HDC01-35-2014 ( Other Identifier: University of Johannesburg )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr J. Pellow, University of Johannesburg
Study Sponsor  ICMJE University of Johannesburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Radmila Razlog, MTechHom University of Johannesburg
PRS Account University of Johannesburg
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP