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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Dental Caries in Children; Dental Caries; Behavior, Child; Early Childhood Caries; Dental Caries Extending Into Dentin
• Intervention / Treatment: Drug: Topical application of 38% Silver Diammine Fluoride Solution; Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54600
      • Crescent Montessori School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Saforide; Riva Star; SDF; 38% Silver Diammine fluoride; Advanatge Arrest
Active Comparator: 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.	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.; Other Names: Saforide; Riva Star; SDF; 38% Silver Diammine fluoride; Advanatge Arrest
Active Comparator: 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.	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.; Other Names: Saforide; Riva Star; SDF; 38% Silver Diammine fluoride; Advanatge Arrest
Experimental: 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.	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.; Other Names: ClinPro White varnish; Sodium fluoride with functionalized tricalcium phosphate; NaF-fTCP
Experimental: 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.	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.; Other Names: ClinPro White varnish; Sodium fluoride with functionalized tricalcium phosphate; NaF-fTCP
Experimental: 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.	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.; Other Names: ClinPro White varnish; Sodium fluoride with functionalized tricalcium phosphate; NaF-fTCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries prevalence	Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition	Baseline
Frequency distribution of caries risk	Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high	Baseline
Mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	Baseline
Patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	Baseline
Mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	Baseline
Mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	Baseline
Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	Baseline
Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	Baseline
Changes in the mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	6 months
Changes in the mean score of patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	6 months
Changes in the mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	6 months
Changes in the mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	6 months
Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	6 months
Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	6 months
Changes in the mean score of oral health impact	Calculated using Urdu-Early Childhood Oral Health Impact Scale form, the answer for each item is on a 5-point scale. The sum score of answers to the 13 questions can range from 0-52. The impact of oral health on life activities is predicted to be greater with a higher score in the summation which denotes a poorer quality of life.	12 months
Changes in the mean score of patient behaviour towards dental treatment	Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive	12 months
Changes in the mean score of pain experience	Calculated using Wong Baker Faces Scale on a range of facial expression where 0 denotes no pain, 2, 4, 6 ,8 and 10 denotes the most painful experience	12 months
Changes in the mean value of caries experience	Calculated by summation of number of decayed, missing and filled surfaces of dentition	12 months
Extent of selected cavitated carious lesion using ICDAS	Coded according to ICDAS-2 scoring system code 3: Moderate enamel breakdown, code 4: Moderate underlying dentinal shadow 5: extensive carious lesion extending to dentin without pulpal involvement	12 months
Extent of selected cavitated carious lesion using FOTI	Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	Baseline
Percentage of dropouts	Frequency of participants which either withdraw and do not consent for follow up	6 months
Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	6 months
Percentage of dropouts	Frequency of participants which either withdraw and do not consent for follow up	12 months
Number of participants reporting adverse events	The frequency of participants reporting fluoride or silver toxicity	12 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: 3M ESPE; SDI Limited
• Investigators: Principal Investigator: Anas Imran Arshad, MSc., BDS, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: child behavior; caries arrest; caries prevention; SDF; Sodium fluoride; oral health-related quality of life; pain experience; NaF-fTCP; Wong-Baker Faces Pain rating scale; silver diammine fluoride; minimal intervention dentistry; Functionalized tricalcium phosphate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: USM/JEPeM/20010069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data will only be used for knowledge transfer and personal information of each patient will be kept private and confidential. After performing data analysis and report writing the collected patient data will be securely transferred to hospital archives which are not accessible without proper identification and authorization. Data from the archives will be automatically erased after two years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No