Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000885897
Ethics application status
Approved
Date submitted
31/05/2021
Date registered
8/07/2021
Date last updated
8/07/2021
Date data sharing statement initially provided
8/07/2021
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
VDT
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
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
Country [1] 308736 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St. Lucia Campus
Brisbane QLD 4067
Country
Australia
Secondary sponsor category [1] 309632 0
Hospital
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308657 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 308657 0
Ethics committee country [1] 308657 0
Australia
Date submitted for ethics approval [1] 308657 0
Approval date [1] 308657 0
31/03/2021
Ethics approval number [1] 308657 0
HREC/2021/QRBW/73658

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 111446 0
+61 7 3365 8013
Fax 111446 0
Email 111446 0
[email protected]
Contact person for public queries
Name 111447 0
Ryan Lee
Address 111447 0
School of Dentistry, The University of Queensland
288 Herston Road
Herston QLD 4006
Country 111447 0
Australia
Phone 111447 0
+61 7 3365 8013
Fax 111447 0
Email 111447 0
[email protected]
Contact person for scientific queries
Name 111448 0
Ryan Lee
Address 111448 0
School of Dentistry, The University of Queensland
288 Herston Road
Herston QLD 4006
Country 111448 0
Australia
Phone 111448 0
+61 7 3365 8013
Fax 111448 0
Email 111448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11860Informed consent form    382097-(Uploaded-31-05-2021-17-32-43)-Study-related document.docx
11861Ethical approval    382097-(Uploaded-31-05-2021-17-33-03)-Study-related document.pdf
11863Study protocol    382097-(Uploaded-31-05-2021-17-36-43)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.