Pulp Disease, DentalNCT07715383
Effect of Different Bioactive Restorative Materials and Techniques on Pulpal Condition
A study testing Bioactive Restorative Materials in people with Pulp Disease, Dental, run by Dina Ashraf at 1 site in Egypt.
Trial summary
Restorative materials play a crucial role in dental treatments, particularly in managing tooth decay and restoring damaged teeth. Their interaction with dental pulp is significant, especially in cases where pulp inflammation is present. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Bioactive Restorative Materials
- 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
- 15 Mar 2026to 30 Apr 2026
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Simple occlusal deep carious lesions.
- ICDAS 5 and 6.
- No restorations with the related teeth.
- Periodontally healthy patient (no bleeding on probing and no radiographic evidence of periodontal bone loss)
- Normal occlusion.
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
Who cannot join
- Vulnerable groups such as pregnant females, breast feeding, prisoners, mentally ill, etc.…
- Cigarette smoking or any form of tobacco consumption.
- Medically compromised patients as diabetes.
- A previously endo treated teeth.
- Ongoing dental or periodontal treatment 12 months before the beginning of the study.
- Presence of periodontal pockets >3 mm in the affected tooth.
- Antibiotics or any medication that might lead to decreased salivary flow.
Trial locations and contacts
1 site in 1 country.
About this study
Restorative materials play a crucial role in dental treatments, particularly in managing tooth decay and restoring damaged teeth. Their interaction with dental pulp is significant, especially in cases where pulp inflammation is present.
When a tooth is compromised, the choice of restorative material can influence the health of the pulp. Certain materials can promote healing and reduce inflammation, while others may exacerbate the condition. For instance, biocompatible materials like glass ionomer or resin-modified glass ionomer have been shown to provide a favorable environment for pulp cells, potentially aiding in the regeneration of dental pulp tissue.
Conversely, materials that are not well-tolerated may lead to further irritation and inflammation, highlighting the importance of selecting appropriate restorative materials to protect pulp vitality and support overall dental health.
Read the detailed description
Different filling materials can significantly influence pulp inflammation, making their selection crucial in restorative dentistry. For instance, traditional amalgam, while robust and durable, may lead to pulp irritation due to its thermal properties and the potential for mercury release, which can trigger inflammatory responses in the surrounding tissue.
Composite resins offer better aesthetics and adhesion but can induce inflammation if not properly cured or if components such as unpolymerized monomers leach into the pulp. Glass ionomer materials, favored for their fluoride release and ability to bond to dentin, generally result in less inflammation and can aid in remineralization; however, their mechanical properties may limit their application in posterior teeth.
Emerging materials, such as biocompatible resin-modified glass ionomers and bioactive materials, aim to minimize pulp inflammation while promoting healing through their inherent chemical properties. Therefore, understanding the interactions between these materials and dental pulp is essential for optimizing restorative outcomes and ensuring patient comfort and health.
Pulp inflammation is closely associated with the release of cytokines, which are crucial mediators in the inflammatory response. When dental pulp tissue is injured or infected, immune cells are activated, leading to the secretion of pro-inflammatory cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). These cytokines play a significant role in recruiting additional immune cells to the site of inflammation, enhancing the inflammatory response and promoting pain. Elevated levels of these cytokines can lead to chronic inflammation, which may further damage pulp tissue and compromise its vitality. Conversely, anti-inflammatory cytokines like interleukin-10 (IL-10) can help regulate this response and promote healing.
The balance between pro-inflammatory and anti-inflammatory cytokines is critical; dysregulation can result in prolonged inflammation and can influence the outcomes of dental treatments.Understanding this relationship is vital for developing therapeutic strategies aimed at managing pulp inflammation and preserving dental health.
Evaluating pulp inflammation through interstitial cervical fluid presents a promising approach for diagnosing and monitoring pulpal health. Interstitial cervical fluid, found in the periodontal tissues around the teeth, can serve as a biochemical marker for inflammatory processes occurring within the dental pulp. When pulp inflammation occurs, cytokines and other inflammatory mediators are released into the surrounding tissues, leading to alterations in the composition of this fluid. By analyzing the levels of specific biomarkers, such as pro-inflammatory cytokines (e.g., IL-1, IL-6, TNF-α) or enzymes like matrix metalloproteinases, clinicians can gain insights into the extent and nature of pulpal inflammation.
This non-invasive method allows for a more nuanced understanding of the inflammatory status of the pulp, enabling timely interventions and more tailored treatment strategies. As research advances, the use of interstitial cervical fluid analysis could become a valuable tool in clinical dentistry for assessing pulpal health and guiding therapeutic decisions.
The methodology for testing interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α) in intracervical fluids typically involves several key steps to ensure accurate measurement of these inflammatory cytokines. First, cervical fluid samples are collected through a minimally invasive procedure, ensuring sterility to avoid contamination.
Following collection, the samples are processed promptly, often by centrifugation, to remove cellular debris. The supernatant is then stored at low temperatures until analysis. Quantification of IL-1 and TNF-α is usually performed using enzyme-linked immunosorbent assay (ELISA), which allows for sensitive and specific detection of these cytokines. The assay involves adding specific antibodies that bind to the target cytokines in the samples, followed by a secondary antibody conjugated to an enzyme.
A genuinely novel substitute for traditional amalgam filling materials is the bioactive powder-liquid filler. Its remarkable endurance, high flexural strength, natural-looking appearance, and bioactive ion release are its defining characteristics. Cention Forte aids in remineralization and demineralization prevention. An advanced ion-releasing mechanism is present in this unique filler substance.
Cention Forte will release hydroxide ions as needed to assist restore pH balance and stop the demineralization of tooth structure if the pH falls as a result of the growth of cariogenic bacteria. In addition, the calcium and fluoride ions that Cention Forte releases can help to prevent secondary cavities and remineralize the toothstructure. Cention Forte and Cention Primer are a well-coordinated system.
Using pre-reacted glass-ionomer technology, surface pre-reacted glass-ionomer (SPRG) filler was created to give restorative materials bioactive properties. Aluminum (Al3+), borate (BO33-), sodium (Na+), silicate (SiO32-), strontium (Sr2+), and fluoride (F-) are the six ions that can be released by the fluoraluminosilicate glass and polyacrylic acid solution that make up SPRG filler. These many ions have the power to give enamel acid resistance and stop demineralization [4,6]. Additionally, research has shown that the ions generated by SPRG may have antibacterial properties, however they are only partially effective in preventing the formation of biofilms or bacterial adhesion
- Conditions
- Pulp Disease, Dental
- Being tested
- Bioactive Restorative Materials
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Restorative MaterialsProcedure or surgery
Also called Techniques
To evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels
| Study group | Role | What they receive |
|---|---|---|
| Surface pre-reacted glass ionomer based injectable composite | Active comparator | Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Surface pre-reacted glass ionomer based injectable composite 10 patient per group Receives: Procedure: Bioactive Restorative Materials |
| Resin modified glass ionomer | Active comparator | Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Resin modified glass ionomer 10 patient per group Receives: Procedure: Bioactive Restorative Materials |
| Cention forte | Active comparator | Restoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Cention forte 10 patient per group Receives: Procedure: Bioactive Restorative Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Pulpal inflammatory responses
(Analysis of the crevicular fluid) (TNF Alpha \& IL1) after using two different filling materials and techniques.
Measured: 1 month
Secondary outcomes (1)
Post-operative pain
Participants will be evaluated for postoperative pain using a Visual Analog Scale (VAS) immediately, after restoration, 1 day and 6 days post-treatment and Pain scores will be collected and categorized as mild (1-3), moderate (4-6), or severe (7-10).
Measured: 1 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Mar 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Disease, DentalStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Ashraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Ashraf, Ain Shams University
- Investigators
- Medhat Taha EL-Faramawy, M.D, Study chair, Professor of Endodontics, Faculty of Dentistry, Ain shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715383
- Sponsor's protocol ID
- Pulpal Condition
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Bioactive Restorative Materials and Techniques on Pulpal Condition
- ClinicalTrials.gov ID
- NCT07715383
- Acronym / sponsor ID
- Pulpal Condition
- Conditions
- Pulp Disease, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dina AshrafUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 20 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.
Restorative materials play a crucial role in dental treatments, particularly in managing tooth decay and restoring damaged teeth. Their interaction with dental pulp is significant, especially in cases where pulp inflammation is present.
When a tooth is compromised, the choice of restorative material can influence the health of the pulp. Certain materials can promote healing and reduce inflammation, while others may exacerbate the condition. For instance, biocompatible materials like glass ionomer or resin-modified glass ionomer have been shown to provide a favorable environment for pulp cells, potentially aiding in the regeneration of dental pulp tissue.
Conversely, materials that are not well-tolerated may lead to further irritation and inflammation, highlighting the importance of selecting appropriate restorative materials to protect pulp vitality and support overall dental health.
Detailed description
Different filling materials can significantly influence pulp inflammation, making their selection crucial in restorative dentistry. For instance, traditional amalgam, while robust and durable, may lead to pulp irritation due to its thermal properties and the potential for mercury release, which can trigger inflammatory responses in the surrounding tissue.
Composite resins offer better aesthetics and adhesion but can induce inflammation if not properly cured or if components such as unpolymerized monomers leach into the pulp. Glass ionomer materials, favored for their fluoride release and ability to bond to dentin, generally result in less inflammation and can aid in remineralization; however, their mechanical properties may limit their application in posterior teeth.
Emerging materials, such as biocompatible resin-modified glass ionomers and bioactive materials, aim to minimize pulp inflammation while promoting healing through their inherent chemical properties. Therefore, understanding the interactions between these materials and dental pulp is essential for optimizing restorative outcomes and ensuring patient comfort and health.
Pulp inflammation is closely associated with the release of cytokines, which are crucial mediators in the inflammatory response. When dental pulp tissue is injured or infected, immune cells are activated, leading to the secretion of pro-inflammatory cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). These cytokines play a significant role in recruiting additional immune cells to the site of inflammation, enhancing the inflammatory response and promoting pain. Elevated levels of these cytokines can lead to chronic inflammation, which may further damage pulp tissue and compromise its vitality. Conversely, anti-inflammatory cytokines like interleukin-10 (IL-10) can help regulate this response and promote healing.
The balance between pro-inflammatory and anti-inflammatory cytokines is critical; dysregulation can result in prolonged inflammation and can influence the outcomes of dental treatments.Understanding this relationship is vital for developing therapeutic strategies aimed at managing pulp inflammation and preserving dental health.
Evaluating pulp inflammation through interstitial cervical fluid presents a promising approach for diagnosing and monitoring pulpal health. Interstitial cervical fluid, found in the periodontal tissues around the teeth, can serve as a biochemical marker for inflammatory processes occurring within the dental pulp. When pulp inflammation occurs, cytokines and other inflammatory mediators are released into the surrounding tissues, leading to alterations in the composition of this fluid. By analyzing the levels of specific biomarkers, such as pro-inflammatory cytokines (e.g., IL-1, IL-6, TNF-α) or enzymes like matrix metalloproteinases, clinicians can gain insights into the extent and nature of pulpal inflammation.
This non-invasive method allows for a more nuanced understanding of the inflammatory status of the pulp, enabling timely interventions and more tailored treatment strategies. As research advances, the use of interstitial cervical fluid analysis could become a valuable tool in clinical dentistry for assessing pulpal health and guiding therapeutic decisions.
The methodology for testing interleukin-1 (IL-1) and tumor necrosis factor-alpha (TNF-α) in intracervical fluids typically involves several key steps to ensure accurate measurement of these inflammatory cytokines. First, cervical fluid samples are collected through a minimally invasive procedure, ensuring sterility to avoid contamination.
Following collection, the samples are processed promptly, often by centrifugation, to remove cellular debris. The supernatant is then stored at low temperatures until analysis. Quantification of IL-1 and TNF-α is usually performed using enzyme-linked immunosorbent assay (ELISA), which allows for sensitive and specific detection of these cytokines. The assay involves adding specific antibodies that bind to the target cytokines in the samples, followed by a secondary antibody conjugated to an enzyme.
A genuinely novel substitute for traditional amalgam filling materials is the bioactive powder-liquid filler. Its remarkable endurance, high flexural strength, natural-looking appearance, and bioactive ion release are its defining characteristics. Cention Forte aids in remineralization and demineralization prevention. An advanced ion-releasing mechanism is present in this unique filler substance.
Cention Forte will release hydroxide ions as needed to assist restore pH balance and stop the demineralization of tooth structure if the pH falls as a result of the growth of cariogenic bacteria. In addition, the calcium and fluoride ions that Cention Forte releases can help to prevent secondary cavities and remineralize the toothstructure. Cention Forte and Cention Primer are a well-coordinated system.
Using pre-reacted glass-ionomer technology, surface pre-reacted glass-ionomer (SPRG) filler was created to give restorative materials bioactive properties. Aluminum (Al3+), borate (BO33-), sodium (Na+), silicate (SiO32-), strontium (Sr2+), and fluoride (F-) are the six ions that can be released by the fluoraluminosilicate glass and polyacrylic acid solution that make up SPRG filler. These many ions have the power to give enamel acid resistance and stop demineralization [4,6]. Additionally, research has shown that the ions generated by SPRG may have antibacterial properties, however they are only partially effective in preventing the formation of biofilms or bacterial adhesion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surface pre-reacted glass ionomer based injectable composite | Active comparator | Procedure: Bioactive Restorative MaterialsRestoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Surface pre-reacted glass ionomer based injectable composite 10 patient per group |
| Resin modified glass ionomer | Active comparator | Procedure: Bioactive Restorative MaterialsRestoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Resin modified glass ionomer 10 patient per group |
| Cention forte | Active comparator | Procedure: Bioactive Restorative MaterialsRestoring molar tooth with class 1 cavity ICDAS score 5 \& 6 with Cention forte 10 patient per group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Simple occlusal deep carious lesions.
- ICDAS 5 and 6.
- No restorations with the related teeth.
- Periodontally healthy patient (no bleeding on probing and no radiographic evidence of periodontal bone loss)
- Normal occlusion.
Key exclusion criteria (7 listed)
- Vulnerable groups such as pregnant females, breast feeding, prisoners, mentally ill, etc.…
- Cigarette smoking or any form of tobacco consumption.
- Medically compromised patients as diabetes.
- A previously endo treated teeth.
- Ongoing dental or periodontal treatment 12 months before the beginning of the study.
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 |
|---|---|---|
| Bioactive Restorative MaterialsAlso: TechniquesTo evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels | Procedure or surgery | Cention forte, Resin modified glass ionomer, Surface pre-reacted glass ionomer based injectable composite |
Primary outcome
Measuring Pulpal inflammatory responses
Time frame: 1 month
(Analysis of the crevicular fluid) (TNF Alpha \& IL1) after using two different filling materials and techniques.
1 secondary outcome
Post-operative pain
Time frame: 1 to 6 days
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 20 Jul 2026.
- Individual participant dataSharing planned: No
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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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.
Medhat Taha EL-Faramawy, M.D study chair
Professor of Endodontics, 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 Bioactive Restorative Materials in people with Pulp Disease, Dental, run by Dina Ashraf 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 6 inclusion and 7 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 20 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.
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?
Measuring Pulpal inflammatory responses (time frame: 1 month). 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 20 Jul 2026.