The Efficacy of OrasaltsTM in the Treatment of Gingivitis

Sponsor

University of Johannesburg (Other)

Overall Status

Completed

CT.gov ID

NCT02168335

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Other: OrasaltsTM Other: Sea salt	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Efficacy of OrasaltsTM in the Treatment of Gingivitis

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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	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
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	Other: Sea salt Unmedicated sea salt

Arm

Intervention/Treatment

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

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

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

Other: Sea salt

Unmedicated sea salt

Outcome Measures

Primary Outcome Measures

Modified Gingival Index (MGI) [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 Outcome Measures

Quantitative Gingival Bleeding Index (QGBI) [8 days]
QGBI will be used by the participants to rate gingival bleeding on a daily basis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Johannesburg	Johannesburg	Gauteng	South Africa	2028

Sponsors and Collaborators

University of Johannesburg

Investigators

Study Director: Radmila Razlog, MTechHom, University of Johannesburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr J. Pellow, Dr, University of Johannesburg

ClinicalTrials.gov Identifier:

NCT02168335

Other Study ID Numbers:

DaSilva200814363
HDC01-35-2014

First Posted:

Jun 20, 2014

Last Update Posted:

May 17, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Gingivitis

Study Results

No Results Posted as of May 17, 2016