Dental CariesNCT06348953
Bioactive Versus Non-Bioactive Restorative System in Deep Carious Molars
A study testing selective caries removal and conventional non-bioactive restorative system and selective caries removal and bioactive restorative system in people with Dental Caries and Dental Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Diseases, Deep Caries
- What is being tested?
- selective caries removal and conventional non-bioactive restorative system and selective caries removal and bioactive restorative system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 15 Mar 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Dental Caries, Dental Diseases, Deep Caries, Tooth Diseases, Tooth Decay, Teeth; Lesion
- Being tested
- selective caries removal and conventional non-bioactive restorative system, selective caries removal and bioactive restorative system
- Keywords
- self-etch adhesive, deep caries in permanent molars, bioactive restorative system, selective caries removal, partial caries removal, selective removal to soft caries, bioactive adhesive, bioactive bond, bioactivity, deep carious molars, rct
- Medical subject headings
- Dental Caries, Stomatognathic Diseases, Tooth Diseases, Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective caries removal and conventional non-bioactive restorative systemOther
conventional dental restorative adhesive and resin based composite
selective caries removal and bioactive restorative systemOther
bioactive dental restorative resin based system
| Study group | Role | What they receive |
|---|---|---|
| Conventional non-bioactive restorative system (Comparator) | Active comparator | deep carious molars restored with conventional resin based restorative system Receives: Other: selective caries removal and conventional non-bioactive restorative system |
| Bioactive system (Intervention) | Active comparator | deep carious molars restored with bioactive resin based restorative system Receives: Other: selective caries removal and bioactive restorative system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5
- excellent(No hypersensitivity,normal vitality
- good(Minor hypersensitivity for a limited time,normal vitality
- satisfactory(Moderate hypersensitivity-Delayed/mild sensitivity;no subjective complaints,no treatment needed
- unsatisfactory(Intense hypersensitivity-Delayed with minor subjective symptoms-No detectable sensitivity-Intervention necessary but not replacement
- poor(Intense, acute pulpitis or non-vital tooth-Endodontic treatment is necessary and restoration replacement
Measured: 18 months
Secondary outcomes (6)
Functional properties - (fracture and retention)
- excelent Frac\&Ret:No fractures /Cracks
- good Frac\&Ret:Small hairline crack
- satisfactory Fract and Ret:Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact
- unsatisfactory Fract and Ret:Material chip damage marginal quality-approximal contacts-Bulk fracture\& partial loss-less than half of restoration
- poor Fracture and Retention:(Partial-complete loss of resto. or multiple fractures)
Measured: 18 months
Functional properties - Approximal anatomical form (contact point and contour)
- excelent Approximal anatomical form (a. contact point b. contour): Normal contact point (floss or 25 μm metal blade can pass) and Normal contour.
- 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.
- 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
- 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)
- 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.
Measured: 18 months
continue Functional properties (Radiographic Examination -when applicable)
- excelent xray:No pathology,harmonious transition between restoration \&Tooth
- good xray:Acceptable material excess present-Positive/negative step present at margin <150 μm
- satisfactory xray:Marginal gap<250 μm-Negative steps visible<250 Μm-No adverse effects Noticed-Poor radiopacity of filling
- unsatisfactory xray:(Marginal gap >250 μm)(Material excess accessible but not removable)(Negative steps >250μm and reparable)
- poor xray:(Secondary caries, large gaps, large overhangs) (Apical pathology) (Fracture/loss of restoration or tooth).
Measured: 18 months
continue Functional properties ( marginal adaptation )
- excelent Marginal Adaptation:Harmonious outline,no gaps,white or discolored lines
- good Marginal Adaptation:Marginal gap(<150 μm),white line-Small marginal fracture removable by polishing-Slight ditching,slight step/flashes,minor irregularities
- satisfactory Marginal Adaptation:Gap<250μm not removable-Several small marginal fractures-Major irregularities,ditching or flash,steps
- unsatisfactory Marginal Adapt.:Gap>250μm or dentine/base exposed-Severe ditching or marginal fract. - Larger irregularities or steps -repair necessary
- poor Marginal Adaptation:Restoration-complete or partial-is loose but in situ-Generalized major gaps or irregularities.
Measured: 18 months
Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
- = excellent (No secondary or primary caries)
- = good (Small and localized 1.Demineralization 2. Erosion or 3. Abfraction)
- = satisfactory (Larger areas of 1.Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed) (Only preventive measures necessary)
- = unsatisfactory (Caries with cavitation and suspected undermining caries) (Erosion in Dentine) (Abrasion/abfraction in dentine) (Localized and accessible can be repaired).
- = poor (Deep caries or exposed dentine that is not accessible for repair of restoration)
Measured: 18 months
Success or Failure
Binary Outcome Success (Score 1,2\&3) Failure (Score 4 \&5)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jun 2024
- Primary completion10 Dec 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ahmed Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348953
- Sponsor's protocol ID
- Bioactive restorative system
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Bioactive Versus Non-Bioactive System for Restoration of Deep Carious Molars Using Selective Caries Removal Technique: 18 Months Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06348953
- Acronym / sponsor ID
- Bioactive restorative system
- Conditions
- Dental Caries, Dental Diseases, Deep Caries, Tooth Diseases, Tooth Decay, Teeth; Lesion
- Keywords
- self-etch adhesive, deep caries in permanent molars, bioactive restorative system, selective caries removal, partial caries removal, selective removal to soft caries, bioactive adhesive, bioactive bond
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 5 Apr 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional non-bioactive restorative system (Comparator) | Active comparator | Other: selective caries removal and conventional non-bioactive restorative systemdeep carious molars restored with conventional resin based restorative system |
| Bioactive system (Intervention) | Active comparator | Other: selective caries removal and bioactive restorative systemdeep carious molars restored with bioactive resin based restorative system |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- Allergy to any restorative materials.
- Patients undergoing orthodontic treatment with fixed appliances.
- Pregnant women.
- Patients with debilitating systemic diseases
- Teeth with previous restorations.
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 |
|---|---|---|
| selective caries removal and conventional non-bioactive restorative systemconventional dental restorative adhesive and resin based composite | Other | Conventional non-bioactive restorative system (Comparator) |
| selective caries removal and bioactive restorative systembioactive dental restorative resin based system | Other | Bioactive system (Intervention) |
Primary outcome
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
6 secondary outcomes
Functional properties - (fracture and retention)
Time frame: 18 months
Functional properties - Approximal anatomical form (contact point and contour)
Time frame: 18 months
continue Functional properties (Radiographic Examination -when applicable)
Time frame: 18 months
continue Functional properties ( marginal adaptation )
Time frame: 18 months
Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
Time frame: 18 months
Success or Failure
Time frame: 18 months
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 3 Jun 2026.
Related trials for Dental Caries
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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 study testing selective caries removal and conventional non-bioactive restorative system and selective caries removal and bioactive restorative system in people with Dental Caries and Dental Diseases, run by Cairo 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 7 inclusion and 10 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 3 Jun 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?
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5 (time frame: 18 months). 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 3 Jun 2026.