Effect of Different Bioactive Restorative Materials and Techniques on Pulpal Condition

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.

Study Overview

• Status: Completed
• Conditions: Pulp Disease, Dental
• Intervention / Treatment: Procedure: Bioactive Restorative Materials

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt
      • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surface pre-reacted glass ionomer based injectable composite; Restoring molar tooth with class 1 cavity ICDAS score 5 & 6 with Surface pre-reacted glass ionomer based injectable composite 10 patient per group	Procedure: Bioactive Restorative Materials; To evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels; Other Names: Techniques
Active Comparator: Resin modified glass ionomer; Restoring molar tooth with class 1 cavity ICDAS score 5 & 6 with Resin modified glass ionomer 10 patient per group	Procedure: Bioactive Restorative Materials; To evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels; Other Names: Techniques
Active Comparator: Cention forte; Restoring molar tooth with class 1 cavity ICDAS score 5 & 6 with Cention forte 10 patient per group	Procedure: Bioactive Restorative Materials; To evaluate the effect of different restorative materials used in deep cavities effect on gingival crevicular fluid inflammatory cytokine levels; Other Names: Techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring Pulpal inflammatory responses	(Analysis of the crevicular fluid) (TNF Alpha & IL1) after using two different filling materials and techniques.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 to 6 days

Collaborators and Investigators

• Sponsor: Dina Ashraf
• Investigators: Study Chair: Medhat Taha EL-Faramawy, M.D, Professor of Endodontics, Faculty of Dentistry, Ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Investigative Techniques; Methods
• Other Study ID Numbers: Pulpal Condition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No