Early Childhood CariesPhase 4NCT05772039
Treatment of Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride Tricalciumphosphate and the Effects on Oral Health Related Quality of Life
A Phase 4 study testing Topical application of 38% Silver Diammine Fluoride Solution and Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish in people with Early Childhood Caries and Dental Caries in Children, run by Universiti Sains Malaysia at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Early Childhood Caries, Dental Caries in Children, Dental Caries Extending Into Dentin
- What is being tested?
- Topical application of 38% Silver Diammine Fluoride Solution and Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jan 2022to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Topical application of 38% Silver Diammine Fluoride Solution, Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish
- 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
- Medical subject headings
- Dental Caries, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of 38% Silver Diammine Fluoride SolutionDrug
Also called Riva Star, 38% Silver Diammine fluoride, SDF, Advanatge Arrest
- 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 VarnishDrug
Also called ClinPro White varnish, Sodium fluoride with functionalized tricalcium phosphate, NaF-fTCP
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Topical application of 38% Silver Diammine Fluoride Solution at Baseline | Active comparator | * 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. Receives: Drug: Topical application of 38% Silver Diammine Fluoride Solution |
| Topical application of 38% Silver Diammine Fluoride Solution at 6 months | Active comparator | * 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. Receives: Drug: Topical application of 38% Silver Diammine Fluoride Solution |
| Topical application of 38% Silver Diammine Fluoride Solution at 12 months | Active comparator | * 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. Receives: Drug: Topical application of 38% Silver Diammine Fluoride Solution |
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline | Experimental | * 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. Receives: 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 | * 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. Receives: 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 | * 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. Receives: Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries prevalence
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Measured: Baseline
Frequency distribution of caries risk
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Measured: 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.
Measured: Baseline
Patient behaviour towards dental treatment
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Measured: 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
Measured: Baseline
Mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Measured: 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
Measured: Baseline
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Measured: 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
Measured: 6 months
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months
Changes in the mean value of caries experience
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Measured: 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
Measured: 12 months
Extent of selected cavitated carious lesion using FOTI
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Measured: 12 months
Secondary outcomes (5)
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Measured: Baseline
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Measured: 6 months
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Measured: 6 months
Percentage of dropouts
Frequency of participants which either withdraw and do not consent for follow up
Measured: 12 months
Number of participants reporting adverse events
The frequency of participants reporting fluoride or silver toxicity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start18 Jan 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- 3M ESPE, SDI Limited
- Responsible party
- Principal investigator, ANAS IMRAN ARSHAD, Universiti Sains Malaysia
- Investigators
- Anas Imran Arshad, MSc., BDS, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772039
- Sponsor's protocol ID
- USM/JEPeM/20010069
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05772039
- Acronym / sponsor ID
- USM/JEPeM/20010069
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- 3M ESPE, SDI Limited
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Topical application of 38% Silver Diammine Fluoride Solution at Baseline | Active comparator | Drug: Topical application of 38% Silver Diammine Fluoride Solution* 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. |
| Topical application of 38% Silver Diammine Fluoride Solution at 6 months | Active comparator | Drug: Topical application of 38% Silver Diammine Fluoride Solution* 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. |
| Topical application of 38% Silver Diammine Fluoride Solution at 12 months | Active comparator | Drug: Topical application of 38% Silver Diammine Fluoride Solution* 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. |
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at baseline | Experimental | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate 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. |
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 6 months | Experimental | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate 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. |
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months | Experimental | Drug: Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical application of 38% Silver Diammine Fluoride SolutionAlso: Riva Star, 38% Silver Diammine fluoride, SDF, Advanatge Arrest* 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 38% Silver Diammine Fluoride Solution at 12 months, Topical application of 38% Silver Diammine Fluoride Solution at 6 months, Topical application of 38% Silver Diammine Fluoride Solution at Baseline |
| Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate VarnishAlso: ClinPro White varnish, Sodium fluoride with functionalized tricalcium phosphate, NaF-fTCP* 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. | Drug | Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish at 12 months, 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 baseline |
Primary outcome
Caries prevalence
Time frame: Baseline
Calculated by the frequency of participants having decayed, missing, filled surfaces of dentition
Frequency distribution of caries risk
Time frame: Baseline
Calculated using Caries Risk Assessment questionnaire, which is denoted as low, moderate or high
Mean score of oral health impact
Time frame: Baseline
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
Time frame: Baseline
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Mean score of pain experience
Time frame: Baseline
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
Time frame: Baseline
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Extent of selected cavitated carious lesion using ICDAS
Time frame: Baseline
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
Time frame: Baseline
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Changes in the mean score of oral health impact
Time frame: 6 months
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
Time frame: 6 months
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Changes in the mean score of pain experience
Time frame: 6 months
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
Time frame: 6 months
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Extent of selected cavitated carious lesion using ICDAS
Time frame: 6 months
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
Time frame: 6 months
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
Changes in the mean score of oral health impact
Time frame: 12 months
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
Time frame: 12 months
Calculated using Frankl behaviour rating scale four category which are: definitely negative, negative, positive, definitely positive
Changes in the mean score of pain experience
Time frame: 12 months
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
Time frame: 12 months
Calculated by summation of number of decayed, missing and filled surfaces of dentition
Extent of selected cavitated carious lesion using ICDAS
Time frame: 12 months
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
Time frame: 12 months
Coded using Fiber optic transillumination device corresponding to ICDAS code 3- code 5
5 secondary outcomes
Number of participants reporting adverse events
Time frame: Baseline
Percentage of dropouts
Time frame: 6 months
Number of participants reporting adverse events
Time frame: 6 months
Percentage of dropouts
Time frame: 12 months
Number of participants reporting adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anas Imran Arshad, MSc., BDS principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical application of 38% Silver Diammine Fluoride Solution and Topical application of 5% Sodium Fluoride with functional Tricalcium phosphate Varnish in people with Early Childhood Caries and Dental Caries in Children, run by Universiti Sains Malaysia at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries prevalence (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.