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Caries Prophylaxis With Flairesse Fluoride Varnish

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ClinicalTrials.gov Identifier: NCT03429829
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborators:
Dental Wellness Trust (DWT)
University of Western Cape (UWC)
Information provided by (Responsible Party):
DMG Dental Material Gesellschaft mbH

Brief Summary:
Clinical study to evaluate the efficiency of Flairesse fluoride varnish in improving dental health in South African school children.

Condition or disease Intervention/treatment Phase
Dental Caries Oral Disease Device: Flairesse varnish Not Applicable

Detailed Description:

Dental caries is a chronic disease that affects most adults and children worldwide. It is especially problematic for people with a low economic status, limited access to oral health care services and a lack of awareness for the need for preventive measures. To improve oral health, it has been suggested that oral health programs should put their efforts into combating risk factors and on developing preventive oral health care initiatives. Particularly, school-based programs and screenings have hereby been suggested as cost-effective and efficient methods to reduce inequalities in access to dental health care. One such program is the LifeSmart toothbrushing program that is organized by the Dental Wellness Trust (DWT) - a 2011 founded dental charity aiming to promote general dental wellness in less fortunate communities through health education and dental care programs for children and elderly alike. The LiveSmart program is running in Khayelitsha, a township in Cape Town, South Africa, and aims to teach children the importance of brushing their teeth and washing their hands as well as eating and drinking healthily.

This clinical study will be conducted within the LiveSmart program aiming to ascertain the caries preventive effect of Flairesse fluoride varnish in addition to the benefits that this program already provides. It will furthermore establish if a fluoride varnish regime can be implemented effectively under sub-optimal conditions in an outreach setting. This trial is designed as a 3-year controlled two armed prospective study. A total of approx. 640 children from the reception grade and grade 1 (age 6-7) of two schools will be recruited into two groups ("Flairesse varnish group" and "Control group"). The effectiveness of Flairesse varnish will be assessed by determining the dental decay (via the decayed, missing and filled surface DMFS/dmfs index) after a 36 months intervention period. During this period, the children will receive either Flairesse varnish or the control treatment every 3 months. Dental decay will be evaluated at baseline as well as after 12, 24 and 36 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Class A and B of the reception grade and grade 1 of two schools will be selected for the treatment group and class C and D into the control group.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Caries Prophylaxis With Flairesse Fluoride Varnish in South African School Children Participating in the LiveSmart Oral Health Program That is Conducted by the Dental Wellness Trust - a Controlled Clinical Trial
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Flairesse varnish

All children in this group will recieve a dental examination (DMFS/dmfs) index at baseline as well as after 12, 24 and 36 months. Directly after the baseline examination Flairesse varnish (40ml) will be applied on all teeth using a soft brush according to manufacturares instructions, including flossing to spread the vanish to proximal areas.

In addition to the intervention, all children will receive supervised toothbrushing throughout the study (treatment as usual) using fluoridated toothpaste (Colgate, fluoride ions 1100 ppm).

Device: Flairesse varnish
Flairesse is applied to enamel and dentine as protective varnish in order to prevent caries formation and to promote remineralization of initial caries. It is also used in the treatment of hypersensitive teeth by sealing dentin tubules and hypersensitive areas at the neck of the tooth and exposed root dentine. Flairesse varnish contains xylitol and fluoride (22,600 ppm). Both components have been well established for oral health by reducing caries prevalence and incidences.

No Intervention: Control

All children in this group will recieve a dental examination (DMFS/dmfs) index at baseline as well as after 12, 24 and 36 months, but they will not receive a sham or placebo treatment.

However, all children will receive supervised toothbrushing throughout the study (treatment as usual) using fluoridated toothpaste (Colgate, fluoride ions 1100 ppm).




Primary Outcome Measures :
  1. Relative change in severe dental decay [ Time Frame: 3 years ]
    The primary outcome analysis is the comparison between the intervention and control group with regard to the percentage of children that experience an increase in the D3MFS/ d3mfs.


Secondary Outcome Measures :
  1. Absolute change in severe dental decay [ Time Frame: 3 years ]
    Comparison between the intervention and control group with regard to the absolute change in D3MFS/ d3mfs during the treatment periode (index at follow-up minus index at baseline).

  2. Absolute change in dental decay [ Time Frame: 3 years ]
    Comparison between the intervention and control group with regard to the absolut change in DMFS/dmfs compared to baseline (index at follow-up minus index at baseline).

  3. Relative change in dental decay [ Time Frame: 3 years ]
    Comparison between the intervention and control group with with regard to the percentage of children that experience an increase in the DMFS/ dmfs index.



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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Reception grad or grade 1 (age 6-7)
  • Signed consent form
  • Good general health

Exclusion Criteria:

  • Any allergies (especially sticking plaster)
  • History of asthma
  • Chronic Ulcerated gums
  • Chronic Stomatis
  • Participation in other study (except LifeSmart)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429829


Contacts
Contact: Linda Greenwall +447944119219 linda.greenwall@hampsteadhealthcare.org.uk
Contact: Neil Myburgh +27213704442 ext 2 nmyburgh@uwc.ac.za

Locations
South Africa
Itsitsa Primary School Recruiting
Mfuleni, Western Cape, South Africa, 7100
Contact: Neil Myburgh       nmyburgh@uwc.ac.za   
Nyameko Primary School Recruiting
Mfuleni, Western Cape, South Africa, 7100
Contact: Neil Myburgh       nmyburgh@uwc.ac.za   
Sponsors and Collaborators
DMG Dental Material Gesellschaft mbH
Dental Wellness Trust (DWT)
University of Western Cape (UWC)

Responsible Party: DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier: NCT03429829     History of Changes
Other Study ID Numbers: Wellflair
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DMG Dental Material Gesellschaft mbH:
Caries
Fluoride Varnish
Dental Health

Additional relevant MeSH terms:
Dental Caries
Mouth Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs