Carious PrimaryPhase 2NCT06991582
Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth
A Phase 2 study testing Injectable composite resin restoration and packable composite in people with Carious Primary and Carious Anteriors, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carious Primary, Carious Anteriors
- What is being tested?
- Injectable composite resin restoration and packable composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2025to 30 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children with caries in primary anterior teeth.
- Caries involving class III, IV, V or multisurface caries
- Restorable anterior teeth
- Pre operative Radiograph showing at least half of the root is not resorbed).
Who cannot join
- Badly decayed non restorable anterior teeth
- Signs and symptoms of root resorption (more than half the root is resorbed)
- Presence of bony resorption
- Presence of pathological root resorption
- Tooth Mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
Cairo
Lecturer, +201111511145, rasha.adel@dentistry.cu.edu.eg
About this study
Official title: Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth: A Randomized Clinical Trial
The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.
- Conditions
- Carious Primary, Carious Anteriors
- Being tested
- Injectable composite resin restoration, packable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable composite resin restorationBiological
Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan)
packable compositeBiological
Packable Composite Beautifil II (Shofu INC., Koyoto, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Injectable composite | Experimental | Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan) Receives: Biological: Injectable composite resin restoration |
| Packable Composite | Active comparator | Packable Composite Beautifil II (Shofu INC., Koyoto, Japan) Receives: Biological: packable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Marginal integrity Measuring Device: Explorer
Measuring unit:
Alpha (A) There is no visible evidence of ditching along the margin of the restoration.
Bravo (B) There is visible evidence of ditching along the margin of the restoration, it is not extending to the dentino-enamel junction.
Charlie (C) There is dentin or base is exposed along the margin of the restoration.
Delta (D) The restoration is mobile, fractured, or missing.
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Color Match Measuring Device: Visual Inspection
Measuring unit:
Alpha (A) The restoration appears to match the shade and translucency of adjacent tooth tissues.
Bravo (B)The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades.
Charlie (C)The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Cavo surface marginal discoloration Measuring Device: Visual Inspection
Measuring unit:
Alpha (A) There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure.
Bravo (B) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.
Charlie (C) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Secondary Caries Measuring Device: Visual Inspection
Measuring unit:
Alpha (A) The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B) There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins)
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Anatomic Contour Measuring Device: Visual Inspection and Explorer
Measuring unit:
Alpha (A) Visual inspection and explorer The restoration is a continuation of existing anatomic form or is slightly flattened. It may be overcontoured. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time.
Bravo (B) A surface concavity is evident. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time, but the dentin or base is not exposed.
Charlie (C) There is a loss of restorative substance such that a surface concavity is evident and the base and/or dentin is exposed.
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Surface Texture Measuring Device: Explorer
Measuring unit:
Alpha (A) Explorer Surface texture similar to polished enamel as determined by means of a sharp explorer.
Bravo (B) Explorer Surface texture gritty or similar to a surface subjects to a white stone or similar to a composite containing supramicron-sized particles.
Charlie (C) Explorer Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
Measured: through study completion, on average of 1 year
Direct Clinical Assessment of Restoration
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Gross Fracture Measuring Device: Visual Inspection
Measuring unit:
Alpha (A) Restoration is intact and fully retained. Bravo (B) Restoration is partially retained with some portion of the restoration still intact.
Charlie (C) Restoration is completely missing.
Measured: through study completion, on average of 1 year
Secondary outcomes (3)
Parents' patient Satisfaction
Measuring Device: Questionnaire Measuring unit: Binary (yes or No)
Measured: immediately after the intervention/procedure
Chair side time
Measuring Device: Stopwatch Measuring unit: Minutes
Measured: immediately after the intervention/procedure
Plaque accumulation
Measuring Device: Plaque index Score by Probe
Measuring unit:
0 : No plaque
- : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only by using the probe on the tooth surface.
- : Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- : Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: through study completion, on average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start28 May 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious PrimaryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry Cairo University. Patients will be carefully assessed for eligibility to participate in our study then a full explanation of the nature of our experiment will be provided for parents or guardian before obtaining the informed consent from them.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Mohamed Elmesbahy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991582
- Sponsor's protocol ID
- 14422023595700
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06991582
- Acronym / sponsor ID
- 14422023595700
- Conditions
- Carious Primary, Carious Anteriors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 28 May 2025 (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 aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be recruited from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry Cairo University. Patients will be carefully assessed for eligibility to participate in our study then a full explanation of the nature of our experiment will be provided for parents or guardian before obtaining the informed consent from them.
| Arm | Type | Receives |
|---|---|---|
| Injectable composite | Experimental | Biological: Injectable composite resin restorationInjectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan) |
| Packable Composite | Active comparator | Biological: packable compositePackable Composite Beautifil II (Shofu INC., Koyoto, Japan) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children with caries in primary anterior teeth.
- Caries involving class III, IV, V or multisurface caries
- Restorable anterior teeth
- Pre operative Radiograph showing at least half of the root is not resorbed).
Key exclusion criteria (5 listed)
- Badly decayed non restorable anterior teeth
- Signs and symptoms of root resorption (more than half the root is resorbed)
- Presence of bony resorption
- Presence of pathological root resorption
- Tooth Mobility
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 |
|---|---|---|
| Injectable composite resin restorationInjectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan) | Biological | Injectable composite |
| packable compositePackable Composite Beautifil II (Shofu INC., Koyoto, Japan) | Biological | Packable Composite |
Primary outcome
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Marginal integrity Measuring Device: Explorer Measuring unit: Alpha (A) There is no visible evidence of ditching along the margin of the restoration. Bravo (B) There is visible evidence of ditching along the margin of the restoration, it is not extending to the dentino-enamel junction. Charlie (C) There is dentin or base is exposed along the margin of the restoration. Delta (D) The restoration is mobile, fractured, or missing.
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Color Match Measuring Device: Visual Inspection Measuring unit: Alpha (A) The restoration appears to match the shade and translucency of adjacent tooth tissues. Bravo (B)The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades. Charlie (C)The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Cavo surface marginal discoloration Measuring Device: Visual Inspection Measuring unit: Alpha (A) There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo (B) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. Charlie (C) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Secondary Caries Measuring Device: Visual Inspection Measuring unit: Alpha (A) The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B) There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins)
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Anatomic Contour Measuring Device: Visual Inspection and Explorer Measuring unit: Alpha (A) Visual inspection and explorer The restoration is a continuation of existing anatomic form or is slightly flattened. It may be overcontoured. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time. Bravo (B) A surface concavity is evident. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time, but the dentin or base is not exposed. Charlie (C) There is a loss of restorative substance such that a surface concavity is evident and the base and/or dentin is exposed.
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Surface Texture Measuring Device: Explorer Measuring unit: Alpha (A) Explorer Surface texture similar to polished enamel as determined by means of a sharp explorer. Bravo (B) Explorer Surface texture gritty or similar to a surface subjects to a white stone or similar to a composite containing supramicron-sized particles. Charlie (C) Explorer Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
Direct Clinical Assessment of Restoration
Time frame: through study completion, on average of 1 year
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Gross Fracture Measuring Device: Visual Inspection Measuring unit: Alpha (A) Restoration is intact and fully retained. Bravo (B) Restoration is partially retained with some portion of the restoration still intact. Charlie (C) Restoration is completely missing.
3 secondary outcomes
Parents' patient Satisfaction
Time frame: immediately after the intervention/procedure
Chair side time
Time frame: immediately after the intervention/procedure
Plaque accumulation
Time frame: through study completion, on average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injectable composite resin restoration and packable composite in people with Carious Primary and Carious Anteriors, run by Cairo 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 5 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: opening soon, as of the sponsor's last update on 28 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bassant Mohamed ElMesbahy (+201127132944, bassant.elmesbahy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct Clinical Assessment of Restoration (time frame: through study completion, on average of 1 year). The study lists 7 primary outcomes in all. 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 28 May 2025.