Back to resultsTreatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
Primary Purpose
Early Childhood Caries, Dental Caries in Children, Dental Caries Extending Into Dentin
Status
Enrolling by invitation
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Topical application of 38% Silver Diammine Fluoride Solution
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
Sponsored by
About this trial
This is an interventional treatment trial for Early Childhood Caries focused on measuring SDF, NaF-fTCP, child behavior, pain experience, Wong-Baker Faces Pain rating scale, oral health-related quality of life, caries arrest, caries prevention, silver diammine fluoride, minimal intervention dentistry, Functionalized tricalcium phosphate, Sodium fluoride
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.
Sites / Locations
- Crescent Montessori School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Topical application of 38% Silver Diammine Fluoride Solution at Baseline
Topical application of 38% Silver Diammine Fluoride Solution at 6 months
Topical application of 38% Silver Diammine Fluoride Solution at 12 months
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months
Arm 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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Caries prevalence
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Frequency distribution of caries risk
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
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.
Patient behaviour towards dental treatment
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
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
Mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
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
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
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.
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
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
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
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
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
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.
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
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
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
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
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Secondary Outcome Measures
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Full Information
NCT ID
NCT05772039
First Posted
February 13, 2023
Last Updated
March 5, 2023
Sponsor
Universiti Sains Malaysia
Collaborators
3M ESPE, SDI Limited
1. Study Identification
Unique Protocol Identification Number
NCT05772039
Brief Title
Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
Collaborators
3M ESPE, SDI Limited
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Caries, Dental Caries in Children, Dental Caries Extending Into Dentin, Dental Caries, Behavior, Child, Quality of Life
Keywords
SDF, NaF-fTCP, child behavior, pain experience, Wong-Baker Faces Pain rating scale, oral health-related quality of life, caries arrest, caries prevention, silver diammine fluoride, minimal intervention dentistry, Functionalized tricalcium phosphate, Sodium fluoride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical application of 38% Silver Diammine Fluoride Solution at Baseline
Arm Type
Active Comparator
Arm 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.
Arm Title
Topical application of 38% Silver Diammine Fluoride Solution at 6 months
Arm Type
Active Comparator
Arm 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.
Arm Title
Topical application of 38% Silver Diammine Fluoride Solution at 12 months
Arm Type
Active Comparator
Arm 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.
Arm Title
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline
Arm Type
Experimental
Arm 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.
Arm Title
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months
Arm Type
Experimental
Arm 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.
Arm Title
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Topical application of 38% Silver Diammine Fluoride Solution
Other Intervention Name(s)
Riva Star, 38% Silver Diammine fluoride, SDF, Advanatge Arrest, Saforide
Intervention Description
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
Intervention Name(s)
Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
Other Intervention Name(s)
ClinPro White varnish, Sodium fluoride with functionalized tricalcium phosphate, NaF-fTCP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caries prevalence
Description
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Time Frame
Baseline
Title
Frequency distribution of caries risk
Description
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Time Frame
Baseline
Title
Mean score of oral health impact
Description
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.
Time Frame
Baseline
Title
Patient behaviour towards dental treatment
Description
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Time Frame
Baseline
Title
Mean score of pain experience
Description
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
Time Frame
Baseline
Title
Mean value of caries experience
Description
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time Frame
Baseline
Title
Extent of selected cavitated carious lesion using ICDAS
Description
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
Time Frame
Baseline
Title
Extent of selected cavitated carious lesion using FOTI
Description
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time Frame
Baseline
Title
Changes in the mean score of oral health impact
Description
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.
Time Frame
6 months
Title
Changes in the mean score of patient behaviour towards dental treatment
Description
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Time Frame
6 months
Title
Changes in the mean score of pain experience
Description
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
Time Frame
6 months
Title
Changes in the mean value of caries experience
Description
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time Frame
6 months
Title
Extent of selected cavitated carious lesion using ICDAS
Description
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
Time Frame
6 months
Title
Extent of selected cavitated carious lesion using FOTI
Description
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time Frame
6 months
Title
Changes in the mean score of oral health impact
Description
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.
Time Frame
12 months
Title
Changes in the mean score of patient behaviour towards dental treatment
Description
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Time Frame
12 months
Title
Changes in the mean score of pain experience
Description
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
Time Frame
12 months
Title
Changes in the mean value of caries experience
Description
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Time Frame
12 months
Title
Extent of selected cavitated carious lesion using ICDAS
Description
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
Time Frame
12 months
Title
Extent of selected cavitated carious lesion using FOTI
Description
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants reporting adverse events
Description
The frequency of participants reporting fluoride or silver toxicity
Time Frame
Baseline
Title
Percentage of dropouts
Description
Frequency of participants which either withdraw and do not consent for follow up
Time Frame
6 months
Title
Number of participants reporting adverse events
Description
The frequency of participants reporting fluoride or silver toxicity
Time Frame
6 months
Title
Percentage of dropouts
Description
Frequency of participants which either withdraw and do not consent for follow up
Time Frame
12 months
Title
Number of participants reporting adverse events
Description
The frequency of participants reporting fluoride or silver toxicity
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Imran Arshad, MSc., BDS
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Crescent Montessori School
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
We'll reach out to this number within 24 hrs