Management of Dental Caries of Primary MolarsNCT06166160
Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars
A study testing Bulk fill flowable composite SDR Dentsply sirona in people with Management of Dental Caries of Primary Molars, run by Ain Shams University at 2 sites in Egypt.
Trial summary
the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Management of Dental Caries of Primary Molars
- What is being tested?
- Bulk fill flowable composite SDR Dentsply sirona
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2022to 1 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4 to 8 years old medically free children.
- Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.
- Children who had at least one active dentinal carious lesion on the proximal surface of primary molars
Who cannot join
- Refusal of the parents to sign the informed consent
- Presence of deep bite or any pictures of malocclusion and parafunctional habits.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of dentistry .Ain shams university
Cairo
Marina F assistant lecturer
- Recruiting
Marina Fakhry Fahmy
Cairo
Marina F assistant lecturer
About this study
Official title: Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial
the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar
Read the detailed description
Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions.
- Being tested
- Bulk fill flowable composite SDR Dentsply sirona
- Keywords
- bulk-fill flowable composite , high viscous GIC ,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk fill flowable composite SDR Dentsply sironaOther
Also called high viscosity glass ionomer cement (EQUIA Forte HT) GC
caries removal in class II cavities of primary molars and application of experminted restorations
| Study group | Role | What they receive |
|---|---|---|
| SDR FLOW + bulk fill flowable | Experimental | in class II cavities of primary molars Receives: Other: Bulk fill flowable composite SDR Dentsply sirona |
| high-viscosity glass ionomer cement (EQUIA Forte) | Active comparator | in class II cavities of primary molars Receives: Other: Bulk fill flowable composite SDR Dentsply sirona |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
The difference in the clinical performance flowable bulk fill composite SDR® flow+ and and high viscous glass-ionomer cement(EQUIA Forte) In Class II cavities in primary molars using FDI criteria
Measured: one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jun 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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 Management of Dental Caries of Primary MolarsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina F Fahmy, MD, Ain Shams University
- Investigators
- Marina F Fahmy, ass.lecturer, Principal investigator, assistant lecturer of pediatric dentistry ,faculty of dentistry ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166160
- Sponsor's protocol ID
- PED22-3D
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study protocol
Publications
Fahmy MF, El-Geleel OA, Anwar MNM, Khattab NMA. Clinical performance of a flowable bulk-fill composite compared with highly viscous glass ionomer cement in class II restorations of primary molars: A 1-year randomized clinical trial. J Am Dent Assoc. 2026 Jun 23:S0002-8177(26)00235-7. doi: 10.1016/j.adaj.2026.03.026. Online ahead of print.
PubMed 42340282
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06166160
- Acronym / sponsor ID
- PED22-3D
- Keywords
- bulk-fill flowable composite , high viscous GIC ,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Dec 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.
the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar
Detailed description
Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDR FLOW + bulk fill flowable | Experimental | Other: Bulk fill flowable composite SDR Dentsply sironain class II cavities of primary molars |
| high-viscosity glass ionomer cement (EQUIA Forte) | Active comparator | Other: Bulk fill flowable composite SDR Dentsply sironain class II cavities of primary molars |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4 to 8 years old medically free children.
- Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.
- Children who had at least one active dentinal carious lesion on the proximal surface of primary molars
Key exclusion criteria (2 listed)
- Refusal of the parents to sign the informed consent
- Presence of deep bite or any pictures of malocclusion and parafunctional habits.
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 |
|---|---|---|
| Bulk fill flowable composite SDR Dentsply sironaAlso: high viscosity glass ionomer cement (EQUIA Forte HT) GCcaries removal in class II cavities of primary molars and application of experminted restorations | Other | SDR FLOW + bulk fill flowable, high-viscosity glass ionomer cement (EQUIA Forte) |
Primary outcome
clinical performance
Time frame: one-year
The difference in the clinical performance flowable bulk fill composite SDR® flow+ and and high viscous glass-ionomer cement(EQUIA Forte) In Class II cavities in primary molars using FDI criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 42340282Fahmy MF, El-Geleel OA, Anwar MNM, Khattab NMA. Clinical performance of a flowable bulk-fill composite compared with highly viscous glass ionomer cement in class II restorations of primary molars: A 1-year randomized clinical trial. J Am Dent Assoc. 2026 Jun 23:S0002-8177(26)00235-7. doi: 10.1016/j.adaj.2026.03.026. Online ahead of print.
- Individual participant dataSharing planned: No. study protocol
Related trials for Management of Dental Caries of Primary Molars
Not yet recruiting
Parental Satisfaction of Hall Technique for Caries Management in Primary Molars
Dental Caries
Enrolling by invitation
Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars.
Dental Caries
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.
Marina F Fahmy, ass.lecturer principal investigator
assistant lecturer of pediatric dentistry ,faculty of dentistry ASU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk fill flowable composite SDR Dentsply sirona in people with Management of Dental Caries of Primary Molars, run by Ain Shams University at 2 sites 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina F Fahmy, MD (01273731722, Dr.marina.fakhry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical performance (time frame: one-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 NCT06166160, 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 12 Dec 2023.