None listed
Conditions
Brief summary
Periodontal inflammation is ultimately responsible for the bone loss and tooth loss in periodontal disease. Previous studies have indicated an association between vitamin D deficiency and both chronic and aggressive periodontitis. We hypothesize that topical application of vitamin D via toothpaste application can lead to an overall therapeutic effect on the etiology and development of periodontal disease. Hence, this clinical research study is to investigate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.
Interventions
All test subjects will be provided with soft-bristled adult toothbrushes, and tubes of commercially available fluoride toothpastes with 0.01% vitamin D3 for the duration of study, 60 days. They will be instructed to brush their teeth for two minutes twice daily (in the morning and evening) with the toothpaste provided (a pea size amount, i.e. approx.. 0.25-0.50g of toothpaste at a time). At 20 days, the subjects will be asked to return any reamining toothpaste and new toothpastes with the vitami
All test subjects will be provided with soft-bristled adult toothbrushes, and tubes of commercially available fluoride toothpastes with 0.01% vitamin D3 for the duration of study, 60 days. They will be instructed to brush their teeth for two minutes twice daily (in the morning and evening) with the toothpaste provided (a pea size amount, i.e. approx.. 0.25-0.50g of toothpaste at a time). At 20 days, the subjects will be asked to return any reamining toothpaste and new toothpastes with the vitamin D3 will be replenished until the following appointment, 60 days.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females, between 18-70 years of age; 2. Availability for the duration of the study; 3. Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc); 4. Willingness to provide information related to their medical history; 5. Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns); 6. Initial gingivitis index average score of 1.5 as determined by the use of the Loe and Silness Gingival Index, more than 30% of bleeding sites and absence of periodontal disease; 7. Informed Consent Form signed.
Exclusion criteria
1. Subjects with Pocket Depth > 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone; 2. Oral pathology or a history of allergy to testing products; 3. Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; 4. Subject participating in any other clinical study; 5. Subject pregnant or breastfeeding; 6. Subject who has co-habitants participating this current clinical trial; 7. Subject allergic to oral care products, personal care consumer products, or their ingredients; 8. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study; 9. Subjects taking Vitamin D supplements 3 months prior to the start of the study; 10. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine); 11. Current smokers and subjects with a history of alcohol or drug abuse; 12. An existing medical condition (eg: diabetic people) which prohibits eating or drinking for periods up to 4 hours.
Outcome results
None listed