NCT05772039

Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life

Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

There is still a need for the assessment of different minimal intervention strategies and treatments focusing on the prevention and arrest of carious lesions of primary molars The evidence-based clinical practice guideline on non-restorative treatments for cavitated carious lesions advocate the use of silver diammine fluoride biannually for high caries risk patients

Detailed description

Although SDF has been proven to be highly effective in carious lesion arrest and prevention, the staining effect, metallic taste due to silver content and the minimal mucosal irritation have been noted as primary cause of disinterest among clinicians in the use of this material. The use of NaF-fTCP as a caries preventive material has not been studied widely. The importance of oral hygiene education and diet modification to achieve an effective caries control has been widely discussed. The off-label use of NaF-fTCP as a caries arresting agent has not been studied on primary dentition. There is a dearth of evidence regarding the effectiveness of NaF-fTCP towards caries arrest and prevention in pragmatic settings. A comparison between the SDF and NaF-fTCP application on the cavitated carious primary molars and their effect on the oral health-related quality of life of the children has not been published in the literature.

Conditions

• Early Childhood Caries
• Dental Caries in Children
• Dental Caries Extending Into Dentin
• Dental Caries
• Behavior, Child
• Quality of Life

Interventions

Type	Name	Description
DRUG	Topical application of 38% Silver Diammine Fluoride Solution	* Application of petroleum jelly on lips and around the mouth for prevention of temporary silver tattoo. * Before SDF application, the affected area will be thoroughly dried and isolated using the cotton rolls or dri-angle. * Isolation throughout the procedure and following three minutes is considered most desirable. * The varnish should be allowed to be in place for 60 seconds. This is the most critical step in the process. Applied varnish will be dried with gentle flow of compressed air. * SDF will be applied with a microbrush to all carious lesions and to all pits and fissures on posterior (molar) teeth for 60 seconds. * To avoid gingival or mucosal irritation, contact of varnish with any oral tissue other than affected area will be avoided. * If the application time is shorter due to unforeseen reasons reapplication will be considered.
DRUG	Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish	* According to manufacturer, Clinpro® White Varnish can be applied to tooth surfaces where plaque is present. A prophylaxis is not required. * The applicator brush provided along is used to thoroughly mix the varnish inside the single-unit dose pack, since components of all sodium fluoride varnishes are separate during storage. * Excessive contact with soft tissue should be avoided. * Only enough varnish to form a thin coating on the desired treatment area should be used. * After application, patient should be instructed to close their mouth to set the varnish. * Rinsing or suctioning immediately after application is not recommended. * The operator might appreciate the formation of a thin coating on the teeth and the patient should be informed that they may feel a thin coating when rubbing the treated area with their tongue.

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-07-15
• Completion: 2023-08-15
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: Pakistan