Deep Carious LesionPhase 4NCT07694661
Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)
A Phase 4 study testing Sonic Fill bulk fill resin composite and SDR flowable bulk fill resin composite in people with Deep Carious Lesion, run by October 6 University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evalute the effect of different resin composite packing techniques on pulpal condition in patient with deep carious occlusal cavities in their molar teeth. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Deep Carious Lesion
- What is being tested?
- Sonic Fill bulk fill resin composite and SDR flowable bulk fill resin composite
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Jan 2026
- Phase
- Phase 4
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.
- Systemically healthy patients.
- Good oral hygiene.
- Available for follow-up appointments.
- Asymptomatic permanent molars with deep occlusal caries ICDAS 5 or 6 carious lesions and healthy periodontium, in normal occlusion with no previous restorations related to the teeth and vital with a positive response to cold testing.
Who cannot join
- Vulnerable populations.
- Tobacco users.
- Medically compromised patients, such as those with diabetes or medications affecting salivary flow were excluded.
- Teeth with prior endodontic treatment, periodontal pockets over 3 mm, or any dental/periodontal therapy within the past 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evalute the effect of different resin composite packing techniques on pulpal condition in patient with deep carious occlusal cavities in their molar teeth. The main questions it aims to answer are:
- Do composite packing technquies cause pulpal inflammatory response ?
- Do composite packing technquies cause post operative pain ? Researchers will compare elastic cavity liner packing techniques to sonic activated and flowable bulk packing techniques to see their effect on pulp condition.
Read more
Participants will :
- Provide an honest medial and dental history to undergo the restorative procedures .
- Report subjective symptons.
- Attend all scheduled follow-ups visit for pulp assessment.
Read the detailed description
This clinical study evaluates the impact of various resin composite packing techniques on pulp inflammation and post-operative condition, specifically comparing the biological and mechanical outcomes of incremental layering of packable composite with flowable liner versus modern bulk-fill strategies as SoniFill bulk fill resin composite and SDR bulk fill composite. The research involves preparing standardized cavities in clinical participants and restoring them using specialized resin materials to determine how different application methods influence polymerization shrinkage stress, marginal adaptation, and dentinal tubule fluid movement. To quantify the subclinical inflammatory response of the pulp, Gingival Crevicular Fluid (GCF) samples are collected from the gingival sulcus of the restored teeth at baseline and specific post-operative intervals (immediately and after one week ) to analyze changes in inflammatory mediators or biomarkers. Simultaneously, the patient's subjective experience of post-operative pain and thermal sensitivity is recorded using the Visual Analog Scale (VAS), where participants mark their level of discomfort on a 10-cm line to provide measurable data on clinical symptoms. By correlating these objective biochemical markers from the GCF with the subjective VAS scores and clinical sensibility testing, the study aims to identify the most effective packing protocol for minimizing C-factor-related stress and protecting the dentin-pulp complex from inflammatory responses.
- Conditions
- Deep Carious Lesion
- Being tested
- Sonic Fill bulk fill resin composite, SDR flowable bulk fill resin composite
- Keywords
- SonicFill , SDR , elastic liner, pulp inflammation , post-operative pain, GCF , TNF-α.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonic Fill bulk fill resin compositeDrug
The SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece. The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity
SDR flowable bulk fill resin compositeProcedure or surgery
SDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured. The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured.
| Study group | Role | What they receive |
|---|---|---|
| Flowable liner and packable composite | No intervention | Following proper administration of local anesthesia , cavity preparation is completed according to the study's standardized dimensions. Isolation is achieved using a rubber dam to ensure a moisture-free operating field. Selective-etch is performed using 37% phosphoric acid, followed by thorough rinsing and gentle air-drying to leave the dentin moist. The bonding agent is applied according to the manufacturer's instructions, gently air-thinned to form a uniform layer, and light-cured for the specified duration. A low-viscosity flowable composite liner is applied to the pulpal floor generally not exceeding 1-2 mm in thickness. he remaining cavity depth is restored using a packable resin composite using an incremental layering technique to minimize polymerization shrinkage stress. Each increment is meticulously adapted to the cavity walls using a hand plugger, anatomically contoured, and light-cured individually from the occlusal surface. |
| Sonic Fill bulk fill resin composite | Experimental | The SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece.
The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity. Receives: Drug: Sonic Fill bulk fill resin composite |
| SDR flowable bulk fill resin composite | Experimental | SDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured.
The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured. Receives: Procedure: SDR flowable bulk fill resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal inflammatory responses.
Immuno-histological analysis of the crevicular fluid to evalute pulpal inflammatory response by quantifying the volume of the pro-inflammatory cytokine TNF-α in GCF that reflect pulpal inflmmation in response to different resin composite packing techniques.
Measured: From enrollment to the end of treatment at one year.
Secondary outcomes (1)
Post-operative pain.
This evaluation is conducted using the Visual Analog Scale (VAS), a validated 10-cm horizontal line where "0" represents "no pain" and "10" represents "the worst imaginable pain." Participants are instructed to record their subjective perception of discomfort at specific post-operative intervals (before treatment and one week following restorative procedures ). To ensure a comprehensive assessment, pain is categorized into spontaneous pain and provoked pain (sensitivity to thermal stimuli or masticatory pressure). This subjective data is then correlated with the biochemical findings from the Gingival Crevicular Fluid (GCF) samples.
Measured: From enrollment to the end of treatment at one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Feb 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Zaki, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694661
- Sponsor's protocol ID
- FDASU-Rec IM012562
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07694661
- Acronym / sponsor ID
- FDASU-Rec IM012562
- Conditions
- Deep Carious Lesion
- Keywords
- SonicFill , SDR , elastic liner, pulp inflammation , post-operative pain, GCF , TNF-α.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 10 Jul 2026 (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 goal of this clinical trial is to evalute the effect of different resin composite packing techniques on pulpal condition in patient with deep carious occlusal cavities in their molar teeth. The main questions it aims to answer are:
- Do composite packing technquies cause pulpal inflammatory response ?
- Do composite packing technquies cause post operative pain ? Researchers will compare elastic cavity liner packing techniques to sonic activated and flowable bulk packing techniques to see their effect on pulp condition.
Participants will :
- Provide an honest medial and dental history to undergo the restorative procedures .
- Report subjective symptons.
- Attend all scheduled follow-ups visit for pulp assessment.
Detailed description
This clinical study evaluates the impact of various resin composite packing techniques on pulp inflammation and post-operative condition, specifically comparing the biological and mechanical outcomes of incremental layering of packable composite with flowable liner versus modern bulk-fill strategies as SoniFill bulk fill resin composite and SDR bulk fill composite. The research involves preparing standardized cavities in clinical participants and restoring them using specialized resin materials to determine how different application methods influence polymerization shrinkage stress, marginal adaptation, and dentinal tubule fluid movement. To quantify the subclinical inflammatory response of the pulp, Gingival Crevicular Fluid (GCF) samples are collected from the gingival sulcus of the restored teeth at baseline and specific post-operative intervals (immediately and after one week ) to analyze changes in inflammatory mediators or biomarkers. Simultaneously, the patient's subjective experience of post-operative pain and thermal sensitivity is recorded using the Visual Analog Scale (VAS), where participants mark their level of discomfort on a 10-cm line to provide measurable data on clinical symptoms. By correlating these objective biochemical markers from the GCF with the subjective VAS scores and clinical sensibility testing, the study aims to identify the most effective packing protocol for minimizing C-factor-related stress and protecting the dentin-pulp complex from inflammatory responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flowable liner and packable composite | No intervention | –Following proper administration of local anesthesia , cavity preparation is completed according to the study's standardized dimensions. Isolation is achieved using a rubber dam to ensure a moisture-free operating field. Selective-etch is performed using 37% phosphoric acid, followed by thorough rinsing and gentle air-drying to leave the dentin moist. The bonding agent is applied according to the manufacturer's instructions, gently air-thinned to form a uniform layer, and light-cured for the specified duration. A low-viscosity flowable composite liner is applied to the pulpal floor generally not exceeding 1-2 mm in thickness. he remaining cavity depth is restored using a packable resin composite using an incremental layering technique to minimize polymerization shrinkage stress. Each increment is meticulously adapted to the cavity walls using a hand plugger, anatomically contoured, and light-cured individually from the occlusal surface. |
| Sonic Fill bulk fill resin composite | Experimental | Drug: Sonic Fill bulk fill resin compositeThe SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece. The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity. |
| SDR flowable bulk fill resin composite | Experimental | Procedure: SDR flowable bulk fill resin compositeSDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured. The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders.
- Systemically healthy patients.
- Good oral hygiene.
- Available for follow-up appointments.
- Asymptomatic permanent molars with deep occlusal caries ICDAS 5 or 6 carious lesions and healthy periodontium, in normal occlusion with no previous restorations related to the teeth and vital with a positive response to cold testing.
Key exclusion criteria (4 listed)
- Vulnerable populations.
- Tobacco users.
- Medically compromised patients, such as those with diabetes or medications affecting salivary flow were excluded.
- Teeth with prior endodontic treatment, periodontal pockets over 3 mm, or any dental/periodontal therapy within the past 12 months.
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 |
|---|---|---|
| Sonic Fill bulk fill resin compositeThe SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece. The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity | Drug | Sonic Fill bulk fill resin composite |
| SDR flowable bulk fill resin compositeSDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured. The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured. | Procedure or surgery | SDR flowable bulk fill resin composite |
Primary outcome
Pulpal inflammatory responses.
Time frame: From enrollment to the end of treatment at one year.
Immuno-histological analysis of the crevicular fluid to evalute pulpal inflammatory response by quantifying the volume of the pro-inflammatory cytokine TNF-α in GCF that reflect pulpal inflmmation in response to different resin composite packing techniques.
1 secondary outcome
Post-operative pain.
Time frame: From enrollment to the end of treatment at one 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 10 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sonic Fill bulk fill resin composite and SDR flowable bulk fill resin composite in people with Deep Carious Lesion, run by October 6 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 5 inclusion and 4 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 10 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pulpal inflammatory responses. (time frame: From enrollment to the end of treatment at 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 10 Jul 2026.