Molar Incisor HypomineralizationNCT05931822
Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar.
A study testing Silver Diamine Fluoride 38% and fluoride varnish in people with Molar Incisor Hypomineralization, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomized clinical trial to compare silver modified glass ionomer restorations to non silver glass ionomer restorations in hypo-mineralized first permanent molars in children and to measure the amount of wear of restoration in both groups along with detecting changes in hypersensitivity in hypomineralized molars in… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Silver Diamine Fluoride 38% and fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Dec 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bilateral first permanent molars affected with molar incisor hypomineralization and with the same ICDAS II score.
- Both chosen molars should be of the same degree of MIH severity.
Who cannot join
- signs and symptoms of irreversible pulpitis or pulp necrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Evaluation of Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar In A Group Of Children"-A Clinical Study
A randomized clinical trial to compare silver modified glass ionomer restorations to non silver glass ionomer restorations in hypo-mineralized first permanent molars in children and to measure the amount of wear of restoration in both groups along with detecting changes in hypersensitivity in hypomineralized molars in both groups after one year follow up.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Silver Diamine Fluoride 38%, fluoride varnish
- Keywords
- MIH, silver diamine fluoride, children, glass ionomer
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride 38%Other
silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar
fluoride varnishOther
fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine fluoride modified glass ionomer restoration | Active comparator | Not described Receives: Other: Silver Diamine Fluoride 38% |
| fluoride varnish and glass ionomer restoration | Active comparator | Not described Receives: Other: fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring surface wear using CAD-CAM software program
impressions were taken after treatment and after one year the two impressions were scanned. The scans were superimposed to compare the surface change. T o standardize the measurements specific selected points on the occlusal surface was used.
Measured: after 1 year
Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria
ART criterion was used to evaluate the restorations done after treatment then once again after one year.
Measured: 1 year
Secondary outcomes (1)
Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)
The molars that were selected for treatment were tested for hypersensitivity. The air was delivered from a standard dental unit air syringe for 1 second at a distance of 1 cm and perpendicular to the occlusal surface of the tooth, before treatment ,after 1 week, 6 months and 12 months.
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Sep 2020
- Primary completion30 Oct 2021
- Study completion1 Dec 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 Molar Incisor HypomineralizationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ehab, Mansoura University
- Investigators
- Abeer Abd Elatiif, professor, Study director, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931822
- Sponsor's protocol ID
- A05031219
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: my research is still under publishing and i am planning to get published within 1-2 months. Data in my research can be shared afterwards.
Publications
Saad AE, Alhosainy AY, Abdellatif AM. "Evaluation of Silver Diamine Fluoride Modified Atraumatic Restorative Treatment (SMART) on hypomineralized first permanent molar"- a randomized controlled clinical study. BMC Oral Health. 2024 Oct 4;24(1):1182. doi: 10.1186/s12903-024-04860-z.
PubMed 39367399
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar In A Group Of Children"-A Clinical Study
- ClinicalTrials.gov ID
- NCT05931822
- Acronym / sponsor ID
- A05031219
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- MIH, silver diamine fluoride, children, glass ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Jul 2023 (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.
A randomized clinical trial to compare silver modified glass ionomer restorations to non silver glass ionomer restorations in hypo-mineralized first permanent molars in children and to measure the amount of wear of restoration in both groups along with detecting changes in hypersensitivity in hypomineralized molars in both groups after one year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine fluoride modified glass ionomer restoration | Active comparator | Other: Silver Diamine Fluoride 38% |
| fluoride varnish and glass ionomer restoration | Active comparator | Other: fluoride varnish |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Bilateral first permanent molars affected with molar incisor hypomineralization and with the same ICDAS II score.
- Both chosen molars should be of the same degree of MIH severity.
Key exclusion criteria (1 listed)
- signs and symptoms of irreversible pulpitis or pulp necrosis.
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 Fluoride 38%silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar | Other | Silver Diamine fluoride modified glass ionomer restoration |
| fluoride varnishfluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar | Other | fluoride varnish and glass ionomer restoration |
Primary outcome
Measuring surface wear using CAD-CAM software program
Time frame: after 1 year
impressions were taken after treatment and after one year the two impressions were scanned. The scans were superimposed to compare the surface change. T o standardize the measurements specific selected points on the occlusal surface was used.
Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria
Time frame: 1 year
ART criterion was used to evaluate the restorations done after treatment then once again after one year.
1 secondary outcome
Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS)
Time frame: after 1 year
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 5 Jul 2023.
- Derived from this study: PubMed 39367399Saad AE, Alhosainy AY, Abdellatif AM. "Evaluation of Silver Diamine Fluoride Modified Atraumatic Restorative Treatment (SMART) on hypomineralized first permanent molar"- a randomized controlled clinical study. BMC Oral Health. 2024 Oct 4;24(1):1182. doi: 10.1186/s12903-024-04860-z.
- Individual participant dataSharing planned: No. my research is still under publishing and i am planning to get published within 1-2 months. Data in my research can be shared afterwards.
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Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
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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.
Abeer Abd Elatiif, professor study director
Mansoura University, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride 38% and fluoride varnish in people with Molar Incisor Hypomineralization, 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 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 5 Jul 2023. 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.
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?
Measuring surface wear using CAD-CAM software program (time frame: after 1 year). The study lists 2 primary outcomes in all. 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 NCT05931822, 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 5 Jul 2023.