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Completed

NCT Number: NCT02168335

The Efficacy of OrasaltsTM in the Treatment of Gingivitis

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OrasaltsTM

Other

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

Sea salt

Other

Unmedicated sea salt

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quantitative Gingival Bleeding Index (QGBI)

    Time frame: 8 days

    QGBI will be used by the participants to rate gingival bleeding on a daily basis.

Sponsors and collaborators

Lead sponsor

University of Johannesburg

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2014
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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