An interventional study of selective caries removal and conventional non-bioactive restorative system and selective caries removal and bioactive restorative system in Dental Caries, Dental Diseases and Deep Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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).
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
deep carious molars restored with conventional resin based restorative system
Other: selective caries removal and conventional non-bioactive restorative system
deep carious molars restored with bioactive resin based restorative system
Other: selective caries removal and bioactive restorative system
conventional dental restorative adhesive and resin based composite
bioactive dental restorative resin based system
Biological properties - Post Operative Hypersensitivity and Vitality-Success rate%-Scoring system:Ordinal1-5
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
Time frame: 18 months
Functional properties - (fracture and retention)
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)
Time frame: 18 months
Functional properties - Approximal anatomical form (contact point and contour)
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.
Time frame: 18 months
continue Functional properties (Radiographic Examination -when applicable)
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).
Time frame: 18 months
continue Functional properties ( marginal adaptation )
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.
Time frame: 18 months
Biological properties (Recurrence of caries (CAR), erosion, abfraction- Scoring system Ordinal 1-5)
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)
Time frame: 18 months
Success or Failure
Binary Outcome Success (Score 1,2\&3) Failure (Score 4 \&5)
Time frame: 18 months
Ran from Jun 2024 to primary completion in Dec 2025, 18 months.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 18 months is above that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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