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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Egypt1 site
  • Ain Shams University Hospitals

    Cairo, Abbasia

Other trials in Egypt

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

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 groups in NCT07715383
Study groupRoleWhat they receive
Surface pre-reacted glass ionomer based injectable compositeActive comparatorRestoring 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 ionomerActive comparatorRestoring 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 forteActive comparatorRestoring 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.

  1. 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)
  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.

  1. First posted20 Jul 2026
  2. Study start15 Mar 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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)
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

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.

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