Oral Health Related Quality of LifeNCT05337449
Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique
A study testing silver diamine fluoride and conventional composite resin restoration in people with Oral Health Related Quality of Life and Early Childhood Caries, run by Cairo University.
Trial summary
The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Related Quality of Life, Early Childhood Caries
- What is being tested?
- silver diamine fluoride and conventional composite resin restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 30 Dec 2023
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children Aged 3 to 5 years, in good general health and medically within normal.
- The parents provided written informed consent.
- Carious vital primary molars with reversible pulpitis.
- Restorable teeth.
- Normal Radiographic findings.
Who cannot join
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial
The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC
Read the detailed description
Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".
Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.
- Being tested
- silver diamine fluoride, conventional composite resin restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver diamine fluorideOther
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries
conventional composite resin restorationOther
Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.
| Study group | Role | What they receive |
|---|---|---|
| silver diamine fluoride | Active comparator | Not described Receives: Other: silver diamine fluoride; Other: conventional composite resin restoration |
| conventional composite resin restoration | Active comparator | Not described Receives: Other: silver diamine fluoride; Other: conventional composite resin restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health to Quality of Life
will be evaluated by a questioner answered by the parents
Measured: 6 month intervene
Secondary outcomes (5)
The cost effectiveness
will be measured using ICER (incremental cost-effectiveness ratio)
Measured: 6 month intervene
Parental satisfaction
will be measured by Direct questioning to the parents.
Measured: 6 month intervene
Side effects
will be measured by Direct questioning to the parents.
Measured: 6 month intervene
Time of the procedure
will be measured by stopwatch
Measured: 6 month intervene
Postoperative pain and sensitivity
will be measured by Visual analogue scale
Measured: 6 month intervene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start15 Jul 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Related Quality of LifeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- for both the intervention group and control group, the procedure and follow up will be done parallel to each other
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gala Sharif Osman, Cairo University
- Investigators
- Gala Osman, BDS, Principal investigator, Cairo UniversitySherine Younes, Professor, Study director, Cairo UniversityPassant Nagii, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337449
- Sponsor's protocol ID
- OHrQL in ECC treated with SDF
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05337449
- Acronym / sponsor ID
- OHrQL in ECC treated with SDF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Apr 2022 (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 clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC
Detailed description
Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".
Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- for both the intervention group and control group, the procedure and follow up will be done parallel to each other
| Arm | Type | Receives |
|---|---|---|
| silver diamine fluoride | Active comparator | Other: silver diamine fluoride, Other: conventional composite resin restoration |
| conventional composite resin restoration | Active comparator | Other: silver diamine fluoride, Other: conventional composite resin restoration |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children Aged 3 to 5 years, in good general health and medically within normal.
- The parents provided written informed consent.
- Carious vital primary molars with reversible pulpitis.
- Restorable teeth.
- Normal Radiographic findings.
Key exclusion criteria (3 listed)
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
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 |
|---|---|---|
| silver diamine fluoridesilver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries | Other | conventional composite resin restoration, silver diamine fluoride |
| conventional composite resin restorationDental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate. | Other | conventional composite resin restoration, silver diamine fluoride |
Primary outcome
Oral Health to Quality of Life
Time frame: 6 month intervene
will be evaluated by a questioner answered by the parents
5 secondary outcomes
The cost effectiveness
Time frame: 6 month intervene
Parental satisfaction
Time frame: 6 month intervene
Side effects
Time frame: 6 month intervene
Time of the procedure
Time frame: 6 month intervene
Postoperative pain and sensitivity
Time frame: 6 month intervene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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.
Gala Osman, BDS principal investigator
Cairo University
Sherine Younes, Professor study director
Cairo University
Passant Nagii, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing silver diamine fluoride and conventional composite resin restoration in people with Oral Health Related Quality of Life and Early Childhood Caries, run by Cairo University.
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 3 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Gala Osman, BDS (+201147456003, gala.osman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health to Quality of Life (time frame: 6 month intervene). 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 15 Jun 2022.