Dental CariesNCT05117268
ASSESSMENT OF SDF vs. GIC AND HALL TECHNIQUE
A study testing SDF Application for caries arrest, Glass ionomer restoration and Hall technique in people with Dental Caries, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Early childhood caries (ECC) ,a global public health problem, highly prevalent and severe with life long implications is entirely preventable. as an alternative to general anesthesia low cost innovative materials such as SDF are promising for low income countries such as Pakistan for reducing the burden of dental… Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- SDF Application for caries arrest, Glass ionomer restoration and Hall technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to Feb 2022
- Phase
- Interventional
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of both genders.
- Age range between 5 to 10 years old.
- Both deciduous maxillary and mandibular untreated teeth.
- Carious teeth categorized as ICDAS code 4, 5 and 6 will be included.
- Active carious lesions on occlusal surface of primary molars
Who cannot join
- Permanent dentition will be excluded from this study
- Primary molar showing signs of irreversible pulpitis
- Patients diagnosed with periapical abscess
- Patients allergic to silver
- Medically compromised or patients with childhood impairment and disability.
- Hemophilic patients
- Epileptic patients
- Non-consenting patients for silver staining
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad, Federal, 46000
Beenish Abbas, FCPS, +923067344984, beenishabbas1982@gmail.com
About this study
Early childhood caries (ECC) ,a global public health problem, highly prevalent and severe with life long implications is entirely preventable.
as an alternative to general anesthesia low cost innovative materials such as SDF are promising for low income countries such as Pakistan for reducing the burden of dental caries.
SDF may positively transform prevntive and clinical pediatric dental practices and services in Pakistan.
FDA approves 38% SDF for arresting caries in vulnerable populations.
Read the detailed description
The study will be conducted at Pediatric Dentistry Department of Foundation University College of Dentistry and Hospital. Participants (beneficiary entitled patients consenting for treatment) will be enrolled from patients looking for dental treatment at outpatient pediatric dentistry clinic. Written and verbal informed consent will be taken from each patient guardian. Aims and objectives of study will be clearly explained to participants. Confidentiality will be maintained throughout the study length and right to withdraw from the study will be warranted to all participants. Children will be recruited applying following selection criteria mentioned. Baseline information, like previous dental experience, history of carbonated drinks and dietary sugar intake, experience with local anesthesia, parental education status and socioeconomic status will be recorded. Detailed intra-oral examination will be carried out using mouth mirror, dental probe and triple syringe. Cavitated lesions will be assessed and receive ICDAS score. Cavities with ICDAS code 4, 5 and 6 are to be enrolled in the study. In SDF group, informed consent will be taken from parents, clearly explaining the potential for black staining. Intervention will be performed by trained consultants following the recommended protocol for SDF application: (A) Gross debris will be removed from cavity to allow better contact with SDF; (B) Protective coating of petroleum jelly will be applied to surrounding facial skin and lips to prevent chances of temporary tattoo formation; (C) Area to be treated shall be isolated using cotton rolls and saliva ejectors to prevent gingival irritation; (D) Extra caution will be exercised when applying SDF on primary teeth adjacent to permanent teeth to avoid inadvertent black staining; (E) One drop will be used used for the whole appointment. Bent micro-brush is to be used for application time of 1 min is to be used to reduce systemic absorption; (F) Compressed air shall be applied with gentle flow for up to 3 minutes. Entire dentition will be treated with sodium fluoride varnish to prevent caries.
The lesions of control group glass ionomer restoration group will be treated according to following clinical protocol: (A) Isolation of treatment area using cotton rolls and saliva ejectors; (B) Carious lesion excavation using high speed handpiece; (C) High viscosity glass ionomer cement mixed following manufacturer's instructions; (D) Cavity will be slightly overfilled using a flat plastic instrument, the occlusal surface will be protected with Vaseline and gloved finger will be used to apply slight pressure for 30s. Postoperative instructions will be clearly explained to each patient caregiver. In Hall technique, correct size preformed metal crown will be selected and shall be placed without caries excavation. The crown will be filled with glass ionomer cement and seated with finger pressure. Local anesthesia was not used finger pressure was maintained on the crown until the glass ionomer cement was set.
Primary outcome was caries-arresting potential of all three treatment groups. Recall examination was performed at 6 and 12 months. At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores. Treatment was considered a failure if lesion had progressed to higher score at review examination. Presence of spontaneous pain, sensitivity to percussion and periapical swelling was also considered a failure. Visual and tactile examination was also done to check if the lesion was hard on gentle probing. Secondary outcome was parental aesthetic perception. Factors such as child anxiety, treatment time, adverse events like gingival irritation, burning of mucosa and bad taste, were all taken into account.
A facial image scale was shown to participants before treatment and immediately after treatment to determine the level of child's anxiety with each treatment. Child patient was asked to select from series of facial expressions (very happy, happy, neutral, unhappy, and very unhappy), the face that best expressed their feeling at that point in time. Time required for each treatment group was calculated using a digital timer. Possible adverse events of each treatment were recorded. Any complaint of sensitivity, gingival irritation, tattoo formation, burning, unpleasant taste, silver allergy and nausea was registered immediately. To assess parental aesthetic perception, they were asked questions like if they were displeased by the appearance of their child, or if the child avoided smiling.
- Conditions
- Dental Caries
- Being tested
- SDF Application for caries arrest, Glass ionomer restoration, Hall technique
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF Application for caries arrestProcedure or surgery
Intervention will be performed by trained consultants following the recommended protocol for SDF application: (A) Gross debris will be removed from cavity to allow better contact with SDF; (B) Protective coating of petroleum jelly will be applied to surrounding facial skin and lips to prevent chances of temporary tattoo formation; (C) Area to be treated shall be isolated using cotton rolls and saliva ejectors to prevent gingival irritation; (D) Extra caution will be exercised when applying SDF on primary teeth adjacent to permanent teeth to avoid inadvertent black staining; (E) One drop will be used used for the whole appointment. Bent micro-brush is to be used for application time of 1 min is to be used to reduce systemic absorption; (F) Compressed air shall be applied with gentle flow for up to 3 minutes. Entire dentition will be treated with sodium fluoride varnish to prevent caries
Glass ionomer restorationProcedure or surgery
The lesions of control group glass ionomer restoration group will be treated according to following clinical protocol: (A) Isolation of treatment area using cotton rolls and saliva ejectors; (B) Carious lesion excavation using high speed handpiece; (C) High viscosity glass ionomer cement mixed following manufacturer's instructions; (D) Cavity will be slightly overfilled using a flat plastic instrument, the occlusal surface will be protected with Vaseline and gloved finger will be used to apply slight pressure for 30s. Postoperative instructions will be clearly explained to each patient caregiver.
Hall techniqueProcedure or surgery
In Hall technique, correct size preformed metal crown will be selected and shall be placed without caries excavation. The crown will be filled with glass ionomer cement and seated with finger pressure. Local anesthesia was not used finger pressure was maintained on the crown until the glass ionomer cement was set.
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Experimental | In the experimental group, 44 children will be provided with SDF application, after gross debris removal to allow better contact of SDF. The entire dentition will be treated with sodium chloride fluoride varnish to prevent caries. Receives: Procedure: SDF Application for caries arrest |
| Glass Ionomer Restoration | Placebo comparator | In placebo control group n= 44 participants will be enrolled. High viscosity glass ionomer restoration will be placed after complete caries excavation using high-speed handpiece and air/water coolant. Patient will be dispensed with clear postoperative instructions. Receives: Procedure: Glass ionomer restoration |
| Hall Technique | Active comparator | In active comparator group, n= 44 study participants will be enrolled. Pre-formed metal crowns will be selected according to the tooth size and filled with low viscosity glass ionomer cement and seated using digital/ finger pressure. Receives: Procedure: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arresting potential of all 3 treatment groups
At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores
Measured: 6 months
Secondary outcomes (4)
Parental aesthetic perception questionnaire.
Measured: 24 hours
Facial Image scale for child anxiety
Measured: 24 hours
Treatment time through digital timer
Measured: 24 hours
Gingival irritation from follow-up interview
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Oct 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A facial image scale shall be shown to participants before treatment and immediately after treatment to determine child anxiety with each treatment where the child will be asked to identify the face that best expressed their feeling at that point of time. Possible adverse events of each treatment shall be recorded by registering any complaint of sensitivity, gingival irritation, tattoo formation, burning, unpleasant taste, silver allergy and nausea. To assess parental aesthetic perception, a questionnaire will be presented that specifically asks if they were annoyed by the appearance of their child, or the child avoided smiling.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117268
- Sponsor's protocol ID
- FUI/CTR/2021/7
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF SDF vs. GIC AND HALL TECHNIQUE
- ClinicalTrials.gov ID
- NCT05117268
- Acronym / sponsor ID
- FUI/CTR/2021/7
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
Early childhood caries (ECC) ,a global public health problem, highly prevalent and severe with life long implications is entirely preventable.
as an alternative to general anesthesia low cost innovative materials such as SDF are promising for low income countries such as Pakistan for reducing the burden of dental caries.
SDF may positively transform prevntive and clinical pediatric dental practices and services in Pakistan.
FDA approves 38% SDF for arresting caries in vulnerable populations.
Detailed description
The study will be conducted at Pediatric Dentistry Department of Foundation University College of Dentistry and Hospital. Participants (beneficiary entitled patients consenting for treatment) will be enrolled from patients looking for dental treatment at outpatient pediatric dentistry clinic. Written and verbal informed consent will be taken from each patient guardian. Aims and objectives of study will be clearly explained to participants. Confidentiality will be maintained throughout the study length and right to withdraw from the study will be warranted to all participants. Children will be recruited applying following selection criteria mentioned. Baseline information, like previous dental experience, history of carbonated drinks and dietary sugar intake, experience with local anesthesia, parental education status and socioeconomic status will be recorded. Detailed intra-oral examination will be carried out using mouth mirror, dental probe and triple syringe. Cavitated lesions will be assessed and receive ICDAS score. Cavities with ICDAS code 4, 5 and 6 are to be enrolled in the study. In SDF group, informed consent will be taken from parents, clearly explaining the potential for black staining. Intervention will be performed by trained consultants following the recommended protocol for SDF application: (A) Gross debris will be removed from cavity to allow better contact with SDF; (B) Protective coating of petroleum jelly will be applied to surrounding facial skin and lips to prevent chances of temporary tattoo formation; (C) Area to be treated shall be isolated using cotton rolls and saliva ejectors to prevent gingival irritation; (D) Extra caution will be exercised when applying SDF on primary teeth adjacent to permanent teeth to avoid inadvertent black staining; (E) One drop will be used used for the whole appointment. Bent micro-brush is to be used for application time of 1 min is to be used to reduce systemic absorption; (F) Compressed air shall be applied with gentle flow for up to 3 minutes. Entire dentition will be treated with sodium fluoride varnish to prevent caries.
The lesions of control group glass ionomer restoration group will be treated according to following clinical protocol: (A) Isolation of treatment area using cotton rolls and saliva ejectors; (B) Carious lesion excavation using high speed handpiece; (C) High viscosity glass ionomer cement mixed following manufacturer's instructions; (D) Cavity will be slightly overfilled using a flat plastic instrument, the occlusal surface will be protected with Vaseline and gloved finger will be used to apply slight pressure for 30s. Postoperative instructions will be clearly explained to each patient caregiver. In Hall technique, correct size preformed metal crown will be selected and shall be placed without caries excavation. The crown will be filled with glass ionomer cement and seated with finger pressure. Local anesthesia was not used finger pressure was maintained on the crown until the glass ionomer cement was set.
Primary outcome was caries-arresting potential of all three treatment groups. Recall examination was performed at 6 and 12 months. At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores. Treatment was considered a failure if lesion had progressed to higher score at review examination. Presence of spontaneous pain, sensitivity to percussion and periapical swelling was also considered a failure. Visual and tactile examination was also done to check if the lesion was hard on gentle probing. Secondary outcome was parental aesthetic perception. Factors such as child anxiety, treatment time, adverse events like gingival irritation, burning of mucosa and bad taste, were all taken into account.
A facial image scale was shown to participants before treatment and immediately after treatment to determine the level of child's anxiety with each treatment. Child patient was asked to select from series of facial expressions (very happy, happy, neutral, unhappy, and very unhappy), the face that best expressed their feeling at that point in time. Time required for each treatment group was calculated using a digital timer. Possible adverse events of each treatment were recorded. Any complaint of sensitivity, gingival irritation, tattoo formation, burning, unpleasant taste, silver allergy and nausea was registered immediately. To assess parental aesthetic perception, they were asked questions like if they were displeased by the appearance of their child, or if the child avoided smiling.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A facial image scale shall be shown to participants before treatment and immediately after treatment to determine child anxiety with each treatment where the child will be asked to identify the face that best expressed their feeling at that point of time. Possible adverse events of each treatment shall be recorded by registering any complaint of sensitivity, gingival irritation, tattoo formation, burning, unpleasant taste, silver allergy and nausea. To assess parental aesthetic perception, a questionnaire will be presented that specifically asks if they were annoyed by the appearance of their child, or the child avoided smiling.
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Procedure: SDF Application for caries arrestIn the experimental group, 44 children will be provided with SDF application, after gross debris removal to allow better contact of SDF. The entire dentition will be treated with sodium chloride fluoride varnish to prevent caries. |
| Glass Ionomer Restoration | Placebo comparator | Procedure: Glass ionomer restorationIn placebo control group n= 44 participants will be enrolled. High viscosity glass ionomer restoration will be placed after complete caries excavation using high-speed handpiece and air/water coolant. Patient will be dispensed with clear postoperative instructions. |
| Hall Technique | Active comparator | Procedure: Hall techniqueIn active comparator group, n= 44 study participants will be enrolled. Pre-formed metal crowns will be selected according to the tooth size and filled with low viscosity glass ionomer cement and seated using digital/ finger pressure. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of both genders.
- Age range between 5 to 10 years old.
- Both deciduous maxillary and mandibular untreated teeth.
- Carious teeth categorized as ICDAS code 4, 5 and 6 will be included.
- Active carious lesions on occlusal surface of primary molars
Key exclusion criteria (8 listed)
- Permanent dentition will be excluded from this study
- Primary molar showing signs of irreversible pulpitis
- Patients diagnosed with periapical abscess
- Patients allergic to silver
- Medically compromised or patients with childhood impairment and disability.
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 |
|---|---|---|
| SDF Application for caries arrestIntervention will be performed by trained consultants following the recommended protocol for SDF application: (A) Gross debris will be removed from cavity to allow better contact with SDF; (B) Protective coating of petroleum jelly will be applied to surrounding facial skin and lips to prevent chances of temporary tattoo formation; (C) Area to be treated shall be isolated using cotton rolls and saliva ejectors to prevent gingival irritation; (D) Extra caution will be exercised when applying SDF on primary teeth adjacent to permanent teeth to avoid inadvertent black staining; (E) One drop will be used used for the whole appointment. Bent micro-brush is to be used for application time of 1 min is to be used to reduce systemic absorption; (F) Compressed air shall be applied with gentle flow for up to 3 minutes. Entire dentition will be treated with sodium fluoride varnish to prevent caries | Procedure or surgery | Silver Diamine Fluoride |
| Glass ionomer restorationThe lesions of control group glass ionomer restoration group will be treated according to following clinical protocol: (A) Isolation of treatment area using cotton rolls and saliva ejectors; (B) Carious lesion excavation using high speed handpiece; (C) High viscosity glass ionomer cement mixed following manufacturer's instructions; (D) Cavity will be slightly overfilled using a flat plastic instrument, the occlusal surface will be protected with Vaseline and gloved finger will be used to apply slight pressure for 30s. Postoperative instructions will be clearly explained to each patient caregiver. | Procedure or surgery | Glass Ionomer Restoration |
| Hall techniqueIn Hall technique, correct size preformed metal crown will be selected and shall be placed without caries excavation. The crown will be filled with glass ionomer cement and seated with finger pressure. Local anesthesia was not used finger pressure was maintained on the crown until the glass ionomer cement was set. | Procedure or surgery | Hall Technique |
Primary outcome
Caries arresting potential of all 3 treatment groups
Time frame: 6 months
At each recall, ICDAS scores were compared to initial values of teeth. Treatment was classified as success when caries on teeth was classified as inactive based on lower ICDAS score compared to initial scores
4 secondary outcomes
Parental aesthetic perception questionnaire.
Time frame: 24 hours
Facial Image scale for child anxiety
Time frame: 24 hours
Treatment time through digital timer
Time frame: 24 hours
Gingival irritation from follow-up interview
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDF Application for caries arrest, Glass ionomer restoration and Hall technique in people with Dental Caries, run by Foundation University Islamabad 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 5 inclusion and 8 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 11 Nov 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Dr. Beenish Abbas, FCPS (+923067344984, beenishabbas1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries arresting potential of all 3 treatment groups (time frame: 6 months). 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 11 Nov 2021.