Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars

June 1, 2026 updated by: Ahmed Mahmoud Ahmed Mohammed, Cairo University

Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial

This research study delves into the effectiveness of bioactive and non-bioactive restorative systems in deep carious permanent molars treated with selective caries removal. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue. The study investigates how the choice of restorative material influences the outcomes of selective caries removal procedures in deep carious lesions. By assessing factors such as restoration integrity, pulpal response, and long-term success rates, the research seeks to provide evidence-based insights into the comparative performance of bioactive and non-bioactive restorative systems in this clinical context.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Deep carious lesions in permanent molars present a significant challenge in restorative dentistry. Traditional approaches to caries removal often involve the removal of excessive healthy tooth structure, leading to weakened teeth and potential pulp exposure. Selective caries removal techniques aim to preserve as much healthy tooth structure as possible while effectively eliminating carious tissue, offering a conservative alternative to traditional methods. In recent years, bioactive restorative materials have emerged as promising alternatives to conventional non-bioactive materials. Bioactive materials are designed to interact with the biological environment, promoting remineralization and potentially enhancing the longevity of restorations. However, limited evidence exists comparing the efficacy of bioactive and non-bioactive restorative systems in deep carious lesions treated with selective caries removal. This study is designed as a prospective, randomized controlled trial. Patients presenting with deep carious lesions in permanent molars will be randomly allocated to receive either a bioactive or non-bioactive restorative system following selective caries removal. Baseline demographic and clinical data will be recorded for each participant. Clinical evaluations will be conducted at regular intervals over a follow-up period of months. Outcome measures will include restoration integrity (e.g retention, marginal adaptation), pulpal response (e.g., sensitivity, vitality).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry - Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • young adult patients (age: 18-40 years) of both genders.
  • Able to tolerate necessary restorative procedures.
  • Willing to sign the informed consent.
  • Accepts the follow-up period.
  • Posterior permanent tooth with occlusal proximal deep carious lesion.
  • Radiographically (bitewing radiograph) extending to the inner 1/3 of dentine (D3) with a radiopaque layer between the carious lesion and the pulp chamber.
  • Sensible teeth according to cold pulp test.

Exclusion criteria:

  • Allergy to any restorative materials.
  • Patients undergoing orthodontic treatment with fixed appliances.
  • Pregnant women.
  • Patients with debilitating systemic diseases
  • Teeth with previous restorations.
  • Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
  • Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Cervical carious lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional non-bioactive restorative system (Comparator)
deep carious molars restored with conventional resin based restorative system
Other: selective caries removal and conventional non-bioactive restorative system
conventional dental restorative adhesive and resin based composite
Active Comparator: Bioactive system (Intervention)
deep carious molars restored with bioactive resin based restorative system
Other: selective caries removal and bioactive restorative system
bioactive dental restorative resin based system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5
Time Frame: 18 months
  1. excellent(No hypersensitivity,normal vitality
  2. good(Minor hypersensitivity for a limited time,normal vitality
  3. satisfactory(Moderate hypersensitivity-Delayed/mild sensitivity;no subjective complaints,no treatment needed
  4. unsatisfactory(Intense hypersensitivity-Delayed with minor subjective symptoms-No detectable sensitivity-Intervention necessary but not replacement
  5. poor(Intense, acute pulpitis or non-vital tooth-Endodontic treatment is necessary and restoration replacement
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success or Failure
Time Frame: 18 months
Binary Outcome Success (Score 1,2&3) Failure (Score 4 &5)
18 months
Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
Time Frame: 18 months
  1. = excellent (No secondary or primary caries)
  2. = good (Small and localized 1.Demineralization 2. Erosion or 3. Abfraction)
  3. = satisfactory (Larger areas of 1.Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed) (Only preventive measures necessary)
  4. = unsatisfactory (Caries with cavitation and suspected undermining caries) (Erosion in Dentine) (Abrasion/abfraction in dentine) (Localized and accessible can be repaired).
  5. = poor (Deep caries or exposed dentine that is not accessible for repair of restoration)
18 months
Functional properties - (fracture and retention)
Time Frame: 18 months
  1. excelent Frac&Ret:No fractures /Cracks
  2. good Frac&Ret:Small hairline crack
  3. satisfactory Fract and Ret:Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact
  4. unsatisfactory Fract and Ret:Material chip damage marginal quality-approximal contacts-Bulk fracture& partial loss-less than half of restoration
  5. poor Fracture and Retention:(Partial-complete loss of resto. or multiple fractures)
18 months
Functional properties - Approximal anatomical form (contact point and contour)
Time Frame: 18 months
  1. excelent Approximal anatomical form (a. contact point b. contour): Normal contact point (floss or 25 μm metal blade can pass) and Normal contour.
  2. good Approximal anatomical form (a. contact point b. contour): Contact slightly too strong but no disadvantage (floss or 25 μm metal blade can only pass with pressure) and slightly deficient contour.
  3. satisfactory Approximal anatomical form: (a. contact point b. contour): Somewhat weak contact, no indication of damage to tooth, gingiva or periodontal structures; 50 μm metal blade can pass and visible deficient contour
  4. unsatisfactory Approximal anatomical form: (a.contact point b.contour)Too weak and possible damage due to food impaction;100 μm metal blade can pass and Inadequate contour (Repairable)
  5. poor Approx. anatomical form (a.contact point b.contour):Too weak and/or clear damage due to food impaction and/or pain/gingivitis with insufficient contour requires replacement.
18 months
continue Functional properties (Radiographic Examination -when applicable)
Time Frame: 18 months
  1. excelent xray:No pathology,harmonious transition between restoration &Tooth
  2. good xray:Acceptable material excess present-Positive/negative step present at margin <150 μm
  3. satisfactory xray:Marginal gap<250 μm-Negative steps visible<250 Μm-No adverse effects Noticed-Poor radiopacity of filling
  4. unsatisfactory xray:(Marginal gap >250 μm)(Material excess accessible but not removable)(Negative steps >250μm and reparable)
  5. poor xray:(Secondary caries, large gaps, large overhangs) (Apical pathology) (Fracture/loss of restoration or tooth).
18 months
continue Functional properties ( marginal adaptation )
Time Frame: 18 months
  1. excelent Marginal Adaptation:Harmonious outline,no gaps,white or discolored lines
  2. good Marginal Adaptation:Marginal gap(<150 μm),white line-Small marginal fracture removable by polishing-Slight ditching,slight step/flashes,minor irregularities
  3. satisfactory Marginal Adaptation:Gap<250μm not removable-Several small marginal fractures-Major irregularities,ditching or flash,steps
  4. unsatisfactory Marginal Adapt.:Gap>250μm or dentine/base exposed-Severe ditching or marginal fract. - Larger irregularities or steps -repair necessary
  5. poor Marginal Adaptation:Restoration-complete or partial-is loose but in situ-Generalized major gaps or irregularities.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bioactive restorative system

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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