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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical research study to evaluate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.
Scientific title
Clinical research study to evaluate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.
Secondary ID [1] 304364 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingivitis 322149 0
Condition category
Condition code
Oral and Gastrointestinal 319843 319843 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 320724 0
Treatment: Other
Comparator / control treatment
Control group will receive a conventional toothpaste without containing vitamin D substance. Only difference between the control and test groups is the presence of vitamin D in the toothpastes.
Control group

Primary outcome [1] 327711 0
Gingival index changes
Timepoint [1] 327711 0
Baseline, 20 and 60 days (Primary endpoint)
Primary outcome [2] 328040 0
Plaque Index chnages
Timepoint [2] 328040 0
Baseline, 20 and 60 days (Primary endpoint)
Primary outcome [3] 328041 0
Inflammatory cytokine level changes (IL-1a, b, TNF-a, IL-10, MCP-1, MIP-1, MIP-2, IL-6, Il-13) in gingival crevicular fluids (GCFs) - Exploratory outcome
Timepoint [3] 328041 0
Baseline, 20 and 60 days (Primary endpoint)
Secondary outcome [1] 396310 0
Inflammatory cytokine (IL-1a, b, TNF-a, IL-10, MCP-1, MIP-1, MIP-2, IL-6, Il-13) level changes in Saliva - Exploratory outcome
Timepoint [1] 396310 0
Baseline, 20 and 60 days (Primary endpoint)
Secondary outcome [2] 397315 0
Serum Vit D level changes in blood
Timepoint [2] 397315 0
Baseline and 60 days

Key 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.
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation, VEEVA)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
An analysis of covariance will be performed on the change from baseline scores data as a covariate. Age and gender will be included as a covariate, if a difference is significant at baseline. The F-test in this analysis will test the null hypothesis that the adjusted treatment group means are equal. If the F-test shows a significant difference among the groups at the 0.05 level, then a Tukey’s multiple comparison test (2-sided) will be performed on each of the pair as a post- hoc multiple comparison evaluation. The paired comparisons will be determined significant at the 0.05 level.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 34236 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 308736 0
Commercial sector/Industry
Name [1] 308736 0
Colgate - Palmolive Pty Ltd
Address [1] 308736 0
Level 14, 345 George Street, Sydney, NSW 2000
Country [1] 308736 0
Primary sponsor type
The University of Queensland
The University of Queensland
St. Lucia Campus
Brisbane QLD 4067
Secondary sponsor category [1] 309632 0
Name [1] 309632 0
Metro-North Hospital and Health Service
Address [1] 309632 0
Redcliffe Hospital
Anzac Avenue
Redcliffe QLD 4020
Country [1] 309632 0

Ethics approval
Ethics application status
Ethics committee name [1] 308657 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 308657 0
Level 2, Building 34
Royal Brisbane & Women’s Hospital
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 308657 0
Date submitted for ethics approval [1] 308657 0
Approval date [1] 308657 0
Ethics approval number [1] 308657 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 111446 0
Dr Ryan Lee
Address 111446 0
School of Dentistry, The University of Queensland
288 Herston Road
Herston QLD 4006
Country 111446 0
Phone 111446 0
+61 7 3365 8013
Fax 111446 0
Email 111446 0
Contact person for public queries
Name 111447 0
Dr Ryan Lee
Address 111447 0
School of Dentistry, The University of Queensland
288 Herston Road
Herston QLD 4006
Country 111447 0
Phone 111447 0
+61 7 3365 8013
Fax 111447 0
Email 111447 0
Contact person for scientific queries
Name 111448 0
Dr Ryan Lee
Address 111448 0
School of Dentistry, The University of Queensland
288 Herston Road
Herston QLD 4006
Country 111448 0
Phone 111448 0
+61 7 3365 8013
Fax 111448 0
Email 111448 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
IPD will not be shared to anyone who are not listed in the ethics approval, as this includes a sensitive personal information.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 11860 0
Informed consent form
Citation [1] 11860 0
Link [1] 11860 0
Email [1] 11860 0
Other [1] 11860 0
Type [2] 11861 0
Ethical approval
Citation [2] 11861 0
Link [2] 11861 0
Email [2] 11861 0
Other [2] 11861 0
Type [3] 11863 0
Study protocol
Citation [3] 11863 0
Link [3] 11863 0
Email [3] 11863 0
Other [3] 11863 0
Summary results
No Results