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

Universiti Sains Malaysia

Status and phase: Invitation-only; Phase 4

Conditions: Behavior, Child; Dental Caries; Dental Caries Extending Into Dentin; Dental Caries in Children; Early Childhood Caries; Quality of Life

Treatments: Drug: Topical application of 38% Silver Diammine Fluoride Solution; Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05772039

USM/JEPeM/20010069

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children will be invited to participate in the trial if they fulfil the entire selection criteria as described below:

• 4 to 6 years-of-age
• Identification of one or more carious primary molars without involvement of the pulp confirmed by bitewing radiographs
• Up to three teeth per each participant will be selected for intervention
• Has normal salivary flow rate
• Does not consume medications regularly for any medical condition
• Has not or will not receive any fluoride therapy or relevant dental therapy from other dental sources within the last six months

Exclusion criteria

Children will be excluded from the trial if they fulfil any of the following criteria:

• Presence of any pain, ulceration, fistula/sinus or an abscess
• Premature hypermobility of carious teeth which can be potentially included in the study
• History of allergy to any product containing silver compounds
• Siblings of the participants will not be allowed to participate to ensure any chance of ECOHIS duplication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 6 patient groups

Topical application of 38% Silver Diammine Fluoride Solution at Baseline

Active Comparator group

Description:

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Treatment:

Drug: Topical application of 38% Silver Diammine Fluoride Solution

Topical application of 38% Silver Diammine Fluoride Solution at 6 months

Active Comparator group

Description:

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Treatment:

Drug: Topical application of 38% Silver Diammine Fluoride Solution

Topical application of 38% Silver Diammine Fluoride Solution at 12 months

Active Comparator group

Description:

* SDF is known for its corrosive nature therefore a plastic container or dappen dish will be used. * 1 drop (0.05 ml) will be dispensed on a plastic container. * 1 drop (2.24 F-ion mg/dose) SDF treats up to 5 tooth surfaces. * Ultrafine microbrushes will be used to apply varnish.

Treatment:

Drug: Topical application of 38% Silver Diammine Fluoride Solution

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline

Experimental group

Description:

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Treatment:

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months

Experimental group

Description:

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Treatment:

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months

Experimental group

Description:

* 0.25 ml of the solution will be used which contains 12.5 mg of fluoride. * Thin layer will be applied with sweeping horizontal brush strokes to all teeth present.

Treatment:

Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish