Caries Prophylaxis With Flairesse Fluoride Varnish
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 02/28/2018 |
| Iliyowasilishwa Kwanza: | 01/28/2018 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 02/04/2018 |
| Iliyotumwa Kwanza: | 02/11/2018 |
| Sasisho la Mwisho Liliwasilishwa: | 03/04/2018 |
| Sasisho la Mwisho Lilichapishwa: | 03/05/2018 |
| Tarehe halisi ya kuanza kwa masomo: | 02/11/2018 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 01/31/2021 |
| Tarehe ya Kukamilisha Utafiti: | 01/31/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: Flairesse varnish
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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). |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 6 Years Kwa 6 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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) |
Matokeo
Hatua za Matokeo ya Msingi
1. Relative change in severe dental decay [3 years]
Hatua za Matokeo ya Sekondari
1. Absolute change in severe dental decay [3 years]
2. Absolute change in dental decay [3 years]
3. Relative change in dental decay [3 years]
