Clinical PerformanceNCT05945758
Esthetic and Clinical Assessment of Injectable Resin Composite Technique
A study testing Injectable resin composite technique. and Conventional layering technique in people with Clinical Performance, run by Cairo University.
Trial summary
injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- Injectable resin composite technique. and Conventional layering technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2025
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sound and vital upper anterior teeth.
- Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.
- Minor misalignment, correction of peg laterals.
Who cannot join
- Non-vital, fractured, or cracked teeth.
- Teeth with caries or in need of replacement of existing restorations.
- Rampant caries, atypical extrinsic staining of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
About this study
Official title: Esthetic and Clinical Assessment of Injectable Resin Composite Technique Compared to Conventional Layering Technique in Patients With Multiple Spacing in the Maxillary Anterior Teeth Area.
injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.
Read the detailed description
The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.
- Conditions
- Clinical Performance
- Being tested
- Injectable resin composite technique., Conventional layering technique
- Keywords
- injectable resin composite, conventional layering technique, FDI, multiple spacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable resin composite technique.Procedure or surgery
Also called Beautiful Flow Plus F03, Medium Viscosity, Shofu Dental
A metal impression tray was filled with transparent vinyl polysiloxane (EXACLEAR, GC) and used to copy the stone model with the wax-up. Then, the replica will be separated from metal tray and a needle-shaped bur will be used to drill holes through the silicone key ending in the middle of the incisal edge. It will be checked whether the holes were large enough to enable the tip of the composite syringe to pass easily and completely. Neighbouring teeth (mesial and distal one) isolated using Teflon tape, as each tooth will individually be restored for establishment of satisfactory contact points. Following etching and rinsing, the tooth dried, and a dental cord (Ultrampak, Ultradent) will be packed into sulcus for mechanical prevention of subgingival composite flow. Then, the transparent silicone index will be placed in the correct intraoral position, and a syringe filled with flowable composite will be inserted through the hole on the incisal edge.
Conventional layering techniqueProcedure or surgery
Also called Enamel and Dentin shades
the palatal surface will be restored by enamel shade; adapted on the index in the spacing area then The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.
| Study group | Role | What they receive |
|---|---|---|
| Spacing in the maxillary anterior teeth area treated with injectable resin composite technique. | Experimental | The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation.
The Spaces will be restored with injectable resin composite. Receives: Procedure: Injectable resin composite technique. |
| Spacing in the maxillary anterior teeth area treated with conventional layering composite technique. | Active comparator | shade mapping of enamel and dentin, then isolation the teeth with rubber dam. Palatal index will be done on waxing up and applied against the palatal surface to check the adaptation of the index. Then, the enamel shade adapted on the index in the spacing area. index will be placed back on the anterior teeth to build the palatal wall. A brush will be used to adapt the composite to the margin. After removing excess material, light curing will be carried out for 20 seconds. The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready. Receives: Procedure: Conventional layering technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Measured: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Secondary outcomes (3)
Change from baseline in Color match and translucency at 6,12,18& 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Measured: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface and marginal staining at 6,12,18& 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Measured: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface lustrous at 6,12,18& 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Measured: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Mokhtar Ali Morad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945758
- Sponsor's protocol ID
- Injection Molding Technique
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic and Clinical Assessment of Injectable Resin Composite Technique Compared to Conventional Layering Technique in Patients With Multiple Spacing in the Maxillary Anterior Teeth Area.
- ClinicalTrials.gov ID
- NCT05945758
- Acronym / sponsor ID
- Injection Molding Technique
- Conditions
- Clinical Performance
- Keywords
- injectable resin composite, conventional layering technique, FDI, multiple spacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 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.
injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.
Detailed description
The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spacing in the maxillary anterior teeth area treated with injectable resin composite technique. | Experimental | Procedure: Injectable resin composite technique.The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The Spaces will be restored with injectable resin composite. |
| Spacing in the maxillary anterior teeth area treated with conventional layering composite technique. | Active comparator | Procedure: Conventional layering techniqueshade mapping of enamel and dentin, then isolation the teeth with rubber dam. Palatal index will be done on waxing up and applied against the palatal surface to check the adaptation of the index. Then, the enamel shade adapted on the index in the spacing area. index will be placed back on the anterior teeth to build the palatal wall. A brush will be used to adapt the composite to the margin. After removing excess material, light curing will be carried out for 20 seconds. The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sound and vital upper anterior teeth.
- Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.
- Minor misalignment, correction of peg laterals.
Key exclusion criteria (5 listed)
- Non-vital, fractured, or cracked teeth.
- Teeth with caries or in need of replacement of existing restorations.
- Rampant caries, atypical extrinsic staining of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
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 resin composite technique.Also: Beautiful Flow Plus F03, Medium Viscosity, Shofu DentalA metal impression tray was filled with transparent vinyl polysiloxane (EXACLEAR, GC) and used to copy the stone model with the wax-up. Then, the replica will be separated from metal tray and a needle-shaped bur will be used to drill holes through the silicone key ending in the middle of the incisal edge. It will be checked whether the holes were large enough to enable the tip of the composite syringe to pass easily and completely. Neighbouring teeth (mesial and distal one) isolated using Teflon tape, as each tooth will individually be restored for establishment of satisfactory contact points. Following etching and rinsing, the tooth dried, and a dental cord (Ultrampak, Ultradent) will be packed into sulcus for mechanical prevention of subgingival composite flow. Then, the transparent silicone index will be placed in the correct intraoral position, and a syringe filled with flowable composite will be inserted through the hole on the incisal edge. | Procedure or surgery | Spacing in the maxillary anterior teeth area treated with injectable resin composite technique. |
| Conventional layering techniqueAlso: Enamel and Dentin shadesthe palatal surface will be restored by enamel shade; adapted on the index in the spacing area then The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready. | Procedure or surgery | Spacing in the maxillary anterior teeth area treated with conventional layering composite technique. |
Primary outcome
Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.
Time frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
3 secondary outcomes
Change from baseline in Color match and translucency at 6,12,18& 24 months.
Time frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface and marginal staining at 6,12,18& 24 months.
Time frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Change from baseline in Surface lustrous at 6,12,18& 24 months.
Time frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable resin composite technique. and Conventional layering technique in people with Clinical Performance, run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change from baseline in Esthetic anatomical form at 6,12,18& 24 months. (time frame: T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.). 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 14 Jul 2023.