The Efficacy of OrasaltsTM in the Treatment of Gingivitis

NCT02168335 | Completed Phase 2 DMC

• 2 other identifiers: DaSilva200814363HDC01-35-2014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Modified Gingival Index (MGI)

  MGI is a non-invasive method, used by the researcher, to assess inflammation of the gingiva in all 40 participants, at each consultation.

  8 days

Secondary Outcomes (1)

• Quantitative Gingival Bleeding Index (QGBI)

  8 days

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

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

Treatment group

Sea salt OTHER

Unmedicated sea salt

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Radmila Razlog, MTechHom

  University of Johannesburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 20, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)