None listed
Conditions
Brief summary
Participants between the age of 18 – 35 yrs old that fulfill the inclusion criteria will be chosen to take part in the study. All participants will be randomly assigned to one of six groups 14 days prior to commencement of the study. All the participants will receive a dental clean and will be advised to stop the use of their regular mouthwash. When the experiment begins (day 0) participants will be advised to follow the experimental oral hygiene protocol. And they will be advised to use one of five mouthwashes (or water which is a negative control). Five different gum measurements will be measured and the soft tissue health will be noted at all four visits from the start of the experimental period. At the last visit participants will be requested to fill a questionnaire form as well. In addition they will also receive a dental clean to remove bacterial accumulation on their teeth and extrinsic tooth staining. There is significant evidence in the current literature that commercial alcohol containing mouthwashes such as Savacol (Registered Trademark) and Listerine (Registered Trademark) reduce bacterial accumulation and gum inflammation. However despite some progress, there is a huge gap in clinical evidence demonstrating the efficacy of commercially available non-alcohol containing mouthwashes such as Savacol (Registered Trademark), Listerine Zero (Registered Trademark) and a herbal mouthwash – Dr Organics Aloe Vera (Registered Trademark) mouthwash, in the prevention of bacterial accumulation and gum inflammation. This study is expected to give us more evidence about the benefits that these non-alcohol containing mouthwashes can provide to our patients.
Interventions
Commercial mouthwashes
1)Listerine with alcohol
a)Active ingredients - Eucalyptol = 0.092%, Menthol = 0.042%, Methyl salicylate = 0.060%, Thymol = 0.064%.
b) Dose = 20ml mouth rinsing for 30 seconds, 2 x daily (morning and night after meals).
c) Duration = 3 weeks
d) Mode of administration = mouth rinsing for 30 seconds
2) Listerine without alcohol
a) Active ingredients - Sodium fluoride = 0.02%
b) Dose = 10ml mouth rinsing for 60 seconds 2 x daily (morning and night after meals).
c)
Commercial mouthwashes 1)Listerine with alcohol a)Active ingredients - Eucalyptol = 0.092%, Menthol = 0.042%, Methyl salicylate = 0.060%, Thymol = 0.064%. b) Dose = 20ml mouth rinsing for 30 seconds, 2 x daily (morning and night after meals). c) Duration = 3 weeks d) Mode of administration = mouth rinsing for 30 seconds 2) Listerine without alcohol a) Active ingredients - Sodium fluoride = 0.02% b) Dose = 10ml mouth rinsing for 60 seconds 2 x daily (morning and night after meals). c)Duration = 3 weeks d) Mode of administration = mouth rinsing for 60 seconds 3)Savacol without alcohol a)Active ingredients - 2mg/ml chlorhexidine gluconate b) Dose = 10 ml mouth rinsing for 60 seconds 2 x daily (morning and night) c)Duration = 3 weeks d) Mode of administration = mouth rinsing for 60 seconds 4)Aloe Vera mouthwash a) Active ingredients - Aloe vera, Peppermint, Tea tree, Icelandic moss, Arnica, Indian Pennywart, Grapefruit seed extract (concentrations of each ingredient have not been specified by the manufacturer). b) Dose = 10ml mouth rinsing for 60 seconds 2 x daily (morning and night). c)Duration = 3 weeks d) Mode of administration = mouth rinsing for 60 seconds 2) Adherence to the intervention will be monitored by weighing the bottles at each visit.
Sponsors
Sydney Dental Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. The absence of untreated caries, secondary caries or faulty restorations. 2. No removable prosthesis or orthodontic appliances (re movable or/and fixed) 3. No oral lesions, no periodontal problems (healthy gingival and periodontium) 4. Generally healthy, no known allergies against ingredients of the mouthwashes 5. Non smokers 6. Last antibiotic treatment atleast 3 months prior to start of the study 7. Participants should not be taking any non steroidal anti-inflammatory drugs in the last 3 months 8. Not using a mouthwash in the last 2 weeks
Exclusion criteria
1. Pregnancy, lactation 2. Any chronic disease 3. Cardiac disease 4. Diseases of the immune system 5. History of rheumatic fever 6. Splenectomy 7. Presence of signs and symptoms of an acute infection in the oral cavity 8. Any prescribed systemic or topical medication except oral contraceptives 9. Use of antibiotics in the last 3 months 10. History of alcohol or drug abuse 11. Participation in other clinical studies in the last 6 months
Outcome results
None listed