Caries ArrestPhase 4NCT05314660
Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children
A Phase 4 study testing 38 % silver diamine fluoride, Atraumatic restorative technique and Ultra conservative dentistry in people with Caries Arrest, run by Mansoura University at 1 site in Egypt.
Trial summary
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Arrest
- What is being tested?
- 38 % silver diamine fluoride, Atraumatic restorative technique and Ultra conservative dentistry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 15 Mar 2022
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children aged 3-5
- residents of mansoura city
- having at least one carious dentine lesion
Who cannot join
- large carious lesions approximating the pulp
- signs of pulpitis, fistula, abscess.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.
Read the detailed description
135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.
The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.
- Conditions
- Caries Arrest
- Being tested
- 38 % silver diamine fluoride, Atraumatic restorative technique, Ultra conservative dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
38 % silver diamine fluorideDrug
Application of 38% SDF on carious dentine lesions.
Atraumatic restorative techniqueProcedure or surgery
Hand excavation of carious dentine followed by application of Glass ionomer
Ultra conservative dentistryProcedure or surgery
Removal of soft dentine and enlarging of cavity to control bio film
| Study group | Role | What they receive |
|---|---|---|
| Silver diamine fluoride group | Experimental | Application of 38% SDF. Receives: Drug: 38 % silver diamine fluoride |
| Atrumatic restorative technique | Experimental | Not described Receives: Procedure: Atraumatic restorative technique |
| Ultra conservative treatment (UCT) | Experimental | Not described Receives: Procedure: Ultra conservative dentistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.
Measured: 1 year
Secondary outcomes (1)
Early childhood oral health impact scale (ECOHIS)
Comprises 13 questions of four domains; child symptoms, function, pscychology and social interactions. Questionnaire answered at the first appointment and 21 days later. Lowest score is 0, highest is 52 and higher score indicates poor oral health related quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Jan 2020
- Primary completion15 Jan 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries ArrestStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 equal groups receiving 3 different protocols
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314660
- Sponsor's protocol ID
- A22080120
- Status last verified
- Jan 2020
- First submitted
- 24 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data regarding the A-ECOHIS will be available to share if needed
Publications
Hamza BE, Attia NM, Abdellatif AM, Hegazy SA. Arresting Active Carious Lesions Using Minimal Intervention Dentistry among a Group of Preschool Children: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent. 2024 Sep;17(9):1018-1024. doi: 10.5005/jp-journals-10005-2927.
PubMed 39664835
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.
- ClinicalTrials.gov ID
- NCT05314660
- Acronym / sponsor ID
- A22080120
- Conditions
- Caries Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 6 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.
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.
Detailed description
135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.
The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 equal groups receiving 3 different protocols
| Arm | Type | Receives |
|---|---|---|
| Silver diamine fluoride group | Experimental | Drug: 38 % silver diamine fluorideApplication of 38% SDF. |
| Atrumatic restorative technique | Experimental | Procedure: Atraumatic restorative technique |
| Ultra conservative treatment (UCT) | Experimental | Procedure: Ultra conservative dentistry |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy children aged 3-5
- residents of mansoura city
- having at least one carious dentine lesion
Key exclusion criteria (2 listed)
- large carious lesions approximating the pulp
- signs of pulpitis, fistula, abscess.
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 |
|---|---|---|
| 38 % silver diamine fluorideApplication of 38% SDF on carious dentine lesions. | Drug | Silver diamine fluoride group |
| Atraumatic restorative techniqueHand excavation of carious dentine followed by application of Glass ionomer | Procedure or surgery | Atrumatic restorative technique |
| Ultra conservative dentistryRemoval of soft dentine and enlarging of cavity to control bio film | Procedure or surgery | Ultra conservative treatment (UCT) |
Primary outcome
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
Time frame: 1 year
Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.
1 secondary outcome
Early childhood oral health impact scale (ECOHIS)
Time frame: 3 months
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 21 Apr 2022.
- Derived from this study: PubMed 39664835Hamza BE, Attia NM, Abdellatif AM, Hegazy SA. Arresting Active Carious Lesions Using Minimal Intervention Dentistry among a Group of Preschool Children: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent. 2024 Sep;17(9):1018-1024. doi: 10.5005/jp-journals-10005-2927.
- Individual participant dataSharing planned: Undecided. The data regarding the A-ECOHIS will be available to share if needed
Related trials for Caries Arrest
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 38 % silver diamine fluoride, Atraumatic restorative technique and Ultra conservative dentistry in people with Caries Arrest, run by Mansoura University 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 3 inclusion and 2 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 21 Apr 2022. 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 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?
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?
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement. (time frame: 1 year). 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 NCT05314660, which also lists 1 linked publication.
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 21 Apr 2022.