Dental Caries Class IINCT06235489
Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars
A study testing Palfique Bulk Flow in people with Dental Caries Class II, run by Ain Shams University at 1 site in Egypt.
Trial summary
evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class II
- What is being tested?
- Palfique Bulk Flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 May 2024
- 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
- Four to 8 years old children
- Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
- Presence of deep bite or any type of malocclusion or parafunctional habits.
- Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).
Who cannot join
- Refusal of the parents to sign the informed consent.
- Presence of deep bite or any type of malocclusion or parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate, 11361
About this study
Official title: "Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"
evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.
Read the detailed description
- Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
- Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
- Each patient will be assigned to one of the two groups.
- Group I (n= 59): Plafique Bulk Flow Composite.
- Group II (n=59): EQUIA Forte Group.
- Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
- Matrix is placed and secured in position.
- One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
- Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
- Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and tooth pastes to use during the study.
- Conditions
- Dental Caries Class II
- Being tested
- Palfique Bulk Flow
- Keywords
- HVGIC, Proximal caries, Bulk-fil flowable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palfique Bulk FlowOther
Also called Equia Forte HT
removal of caries in primary molars and placement of restorative materials
| Study group | Role | What they receive |
|---|---|---|
| Palfique Bulk Flow bulk-fil flowable restorative material | Experimental | Procedure: restoration of proximal cavities of primary molars with bulk-fil flowable composite removal of proximal caries of primary molars and restoration of the cavities prepared by Palfique bulk flow Receives: Other: Palfique Bulk Flow |
| Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement | Active comparator | Procedure: Restoration of proximal cavities of primary molars with highly viscous glass ionomer cement removal of proximal caries of primary molars and restoration of the cavities prepared by the Equia forte HT Receives: Other: Palfique Bulk Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
Evaluate and compare the clinical performance of two commercially available bulk restorative materials (Plafique® Bulk Flow Composite and EQUIA Forte®) for 12 months using the Federation Dentaire Internationale (FDI) criteria when placed in class II cavity in primary molars.
This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion.
Where score 1 indicates clinically excellent/very good (sufficient), 2: clinically good (sufficient), 3: Clinically satisfactory (sufficient), 4: Clinically unsatisfactory (partially insufficient), and finally score 5 indicates clinically poor (entirely insufficient)
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 posted1 Feb 2024
- Study start1 Jun 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries Class IIStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Abdel Azim, Ain Shams University
- Investigators
- Mariem O Wassel, Prof, Study director, Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235489
- Sponsor's protocol ID
- PED 22-5D
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT06235489
- Acronym / sponsor ID
- PED 22-5D
- Conditions
- Dental Caries Class II
- Keywords
- HVGIC, Proximal caries, Bulk-fil flowable composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 1 Feb 2024 (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.
evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.
Detailed description
- Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
- Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.
- Each patient will be assigned to one of the two groups.
- Group I (n= 59): Plafique Bulk Flow Composite.
- Group II (n=59): EQUIA Forte Group.
- Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
- Matrix is placed and secured in position.
- One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
- Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
- Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
- They will be given manual tooth brushes and tooth pastes to use during the study.
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 |
|---|---|---|
| Palfique Bulk Flow bulk-fil flowable restorative material | Experimental | Other: Palfique Bulk FlowProcedure: restoration of proximal cavities of primary molars with bulk-fil flowable composite removal of proximal caries of primary molars and restoration of the cavities prepared by Palfique bulk flow |
| Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement | Active comparator | Other: Palfique Bulk FlowProcedure: Restoration of proximal cavities of primary molars with highly viscous glass ionomer cement removal of proximal caries of primary molars and restoration of the cavities prepared by the Equia forte HT |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Four to 8 years old children
- Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
- Presence of deep bite or any type of malocclusion or parafunctional habits.
- Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).
Key exclusion criteria (2 listed)
- Refusal of the parents to sign the informed consent.
- Presence of deep bite or any type of malocclusion or 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 |
|---|---|---|
| Palfique Bulk FlowAlso: Equia Forte HTremoval of caries in primary molars and placement of restorative materials | Other | Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement, Palfique Bulk Flow bulk-fil flowable restorative material |
Primary outcome
clinical performance
Time frame: one- year
Evaluate and compare the clinical performance of two commercially available bulk restorative materials (Plafique® Bulk Flow Composite and EQUIA Forte®) for 12 months using the Federation Dentaire Internationale (FDI) criteria when placed in class II cavity in primary molars. This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion. Where score 1 indicates clinically excellent/very good (sufficient), 2: clinically good (sufficient), 3: Clinically satisfactory (sufficient), 4: Clinically unsatisfactory (partially insufficient), and finally score 5 indicates clinically poor (entirely insufficient)
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mariem O Wassel, Prof study director
Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palfique Bulk Flow in people with Dental Caries Class II, run by Ain Shams 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 4 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 16 Oct 2026. 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?
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?
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 16 Oct 2026.