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

NCT ID: NCT05772039

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2023-08-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Topical application of 38% Silver Diammine Fluoride Solution at Baseline

• 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.

Group Type: ACTIVE_COMPARATOR

Topical application of 38% Silver Diammine Fluoride Solution

Intervention Type: DRUG

• 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.

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

• 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.

Group Type: ACTIVE_COMPARATOR

Topical application of 38% Silver Diammine Fluoride Solution

Intervention Type: DRUG

• 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.

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

• 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.

Group Type: ACTIVE_COMPARATOR

Topical application of 38% Silver Diammine Fluoride Solution

Intervention Type: DRUG

• 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.

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

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

• 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.

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

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

• 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.

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

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Riva Star; 38% Silver Diammine fluoride; SDF; Advanatge Arrest; Saforide; ClinPro White varnish; Sodium fluoride with functionalized tricalcium phosphate; NaF-fTCP

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M ESPE

INDUSTRY

Sponsor Role: collaborator

SDI Limited

UNKNOWN

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

ANAS IMRAN ARSHAD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anas Imran Arshad, MSc., BDS

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Crescent Montessori School

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

USM/JEPeM/20010069

Identifier Type: -

Identifier Source: org_study_id