Dental CariesPhase 2/3NCT04654624
Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment
A Phase 2/3 study testing SDF and ART in people with Dental Caries and Child Discomfort, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Dental Caries, Child Discomfort
- What is being tested?
- SDF and ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2018to 30 Oct 2019
- Phase
- Phase 2/3
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Negative and definitely negative behavior according to Frankl's behavior rating scale.
- Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.
Who cannot join
- Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial
The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.
Read the detailed description
Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.
- Conditions
- Dental Caries, Child Discomfort
- Being tested
- SDF, ART
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDrug
Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.
ARTDrug
Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Not described Receives: Drug: SDF |
| Atraumatic Restorative Treatment | Active comparator | Not described Receives: Drug: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Pain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.
Measured: 6 months
Secondary outcomes (1)
Parents' acceptability of the treatment modality
It was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start12 Oct 2018
- Primary completion1 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University, Princess Nourah Bint Abdulrahman University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Amel M Ahmed, Phd, Principal investigator, Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi ArabiaHoda M Abdellatif, PhD, Study chair, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USASarah I Baghdady, M.Sc, Study chair, Faculty of Dentistry, Alexandria University, EgyptWafaa E Abdelaziz, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptMona A ElKateb, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654624
- Sponsor's protocol ID
- SDF vs. ART
- Status last verified
- Nov 2020
- First submitted
- 27 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wright GZ, Weinberger SJ, Marti R, Plotzke O. The effectiveness of infiltration anesthesia in the mandibular primary molar region. Pediatr Dent. 1991 Sep-Oct;13(5):278-83.
PubMed 1815200Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04654624
- Acronym / sponsor ID
- SDF vs. ART
- Conditions
- Dental Caries, Child Discomfort
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University, Princess Nourah Bint Abdulrahman University
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 4 Dec 2020 (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.
The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.
Detailed description
Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Drug: SDF |
| Atraumatic Restorative Treatment | Active comparator | Drug: ART |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Negative and definitely negative behavior according to Frankl's behavior rating scale.
- Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.
Key exclusion criteria (1 listed)
- Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.
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 |
|---|---|---|
| SDFSteps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months. | Drug | Silver Diamine Fluoride |
| ARTSteps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly. | Drug | Atraumatic Restorative Treatment |
Primary outcome
Pain perception
Time frame: 6 months
Pain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.
1 secondary outcome
Parents' acceptability of the treatment modality
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Background: PubMed 1815200Wright GZ, Weinberger SJ, Marti R, Plotzke O. The effectiveness of infiltration anesthesia in the mandibular primary molar region. Pediatr Dent. 1991 Sep-Oct;13(5):278-83.
- Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
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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.
Amel M Ahmed, Phd principal investigator
Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
Hoda M Abdellatif, PhD study chair
College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USA
Sarah I Baghdady, M.Sc study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SDF and ART in people with Dental Caries and Child Discomfort, run by Nourhan M.Aly at 1 site in Egypt.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2020. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain perception (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654624, which also lists 2 linked publications.
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 4 Dec 2020.