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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Dr. Beenish Abbas, FCPS contact

+923067344984

beenishabbas1982@gmail.com

Dr. Amal Farooq, BDS contact

+923328260373

amalfarooq24@gmail.com

Pakistan1 site, 1 recruiting
  • Foundation University Islamabad

    Islamabad, Federal, 46000

    Beenish Abbas, FCPS, +923067344984, beenishabbas1982@gmail.com

    Recruiting

Other trials in Pakistan

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 groups in NCT05117268
Study groupRoleWhat they receive
Silver Diamine FluorideExperimentalIn 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 RestorationPlacebo comparatorIn 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 TechniqueActive comparatorIn 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.

  1. 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)
  1. Parental aesthetic perception questionnaire.

    Measured: 24 hours

  2. Facial Image scale for child anxiety

    Measured: 24 hours

  3. Treatment time through digital timer

    Measured: 24 hours

  4. 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.

  1. First posted11 Nov 2021
  2. Study start1 Oct 2021
  3. Primary completionFeb 2022 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

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)
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

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.

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