Dental CariesNCT07762651
Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
A study testing Biodentine, ACTIVA BioACTIVE and glass ionomer cement in people with Dental Caries and Composite Resins, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Composite Resins, Composite Restoration
- What is being tested?
- Biodentine, ACTIVA BioACTIVE and glass ionomer cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2025to 29 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are medically able to undergo routine dental restorative treatment.
- Patients willing and able to provide written informed consent.
- Patients with adequate oral hygiene and periodontal health for participation in the study.
- Patients requiring posterior Class I restorations
Who cannot join
- Patients with systemic conditions that contraindicate routine dental treatment.
- Patients unable or unwilling to provide informed consent.
- Patients with poor compliance or inability to attend scheduled follow-up visits.
- Teeth with clinical or radiographic evidence of irreversible pulpitis, pulp necrosis, or periapical pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations.
Read the detailed description
Thirty patients ranging in age from 20 to 35 years will be enrolled into the study. This study will be designed as a randomized controlled clinical trial including patients requiring six Class I restorations. Participants will be randomly allocated into six groups according to the type of dentin replacement material used: Group I (Biodentin), Group II (Activa Bioactive), Group III (Glass ionomer cement), Group IV (Ever x posterior), and Group V (Flowable resin). Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical evaluation will be performed at baseline and 6, 12, and 18 months using modified FDI criteria, assessing retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and secondary caries. Data will be collected and statistically analyzed
- Conditions
- Dental Caries, Composite Resins, Composite Restoration
- Being tested
- Biodentine, ACTIVA BioACTIVE, glass ionomer cement, everX Posterior, Flowable Resin Composite
- Keywords
- Clinical, FDI criteria, Biodentin, Composite Restorations, Dentin Replacement
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
Biodentine will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions
ACTIVA BioACTIVEOther
ACTIVA BioACTIVE will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
glass ionomer cementOther
Glass ionomer cement will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
everX PosteriorOther
everX Posterior will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
Flowable Resin CompositeOther
Flowable resin composite will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Participants will receive posterior Class I composite restorations incorporating Biodentine as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. Receives: Other: Biodentine |
| ACTIVA BioACTIVE | Experimental | Participants will receive posterior Class I composite restorations incorporating ACTIVA BioACTIVE as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. Receives: Other: ACTIVA BioACTIVE |
| Glass Ionomer Cement | Experimental | Participants will receive posterior Class I composite restorations incorporating conventional glass ionomer cement as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. Receives: Other: glass ionomer cement |
| everX Posterior | Experimental | Participants will receive posterior Class I composite restorations incorporating everX Posterior as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. Receives: Other: everX Posterior |
| Flowable Resin | Experimental | Participants will receive posterior Class I composite restorations incorporating flowable resin composite as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions Receives: Other: Flowable Resin Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal adaptation
Clinical evaluation of marginal adaptation was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was assessed and categorized according to the degree of conformity with the established criteria as follows: score 1, clinically excellent; scores 2 and 3, clinically satisfactory; and scores 4 and 5, clinically inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. Visual assessment was performed under adequate illumination using a high-intensity light source and a dental magnifying loupe to facilitate accurate evaluation. For statistical analysis, the Friedman test was used to assess within-group changes in restoration outcomes across the different follow-up periods. The Kruskal-Wallis test was applied to compare restoration outcomes among the different groups at each corresponding follow-up.
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 posted13 Aug 2026
- Study start12 Aug 2025
- Primary completion27 Mar 2027 (estimated)
- Study completion29 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd El Ghany Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762651
- Sponsor's protocol ID
- Composite Restorations
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed B, Hamama HH, Mahmoud SH. Microshear Bond Strength of Bioactive Materials to Dentin and Resin Composite. Eur J Dent. 2023 Jul;17(3):917-923. doi: 10.1055/s-0042-1756692. Epub 2022 Oct 28.
PubMed 36307111Karale R, Prathima BJ, Prashanth BR, Shivaranjan NS, Jain N. The effect of bulk-fill composites: Activa and Smart Dentin Replacement on cuspal deflection in endodontically treated teeth with different access cavity designs. J Conserv Dent. 2022 Jul-Aug;25(4):375-379. doi: 10.4103/jcd.jcd_53_22. Epub 2022 Aug 2.
PubMed 36187866Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
PubMed 35656656Hafez ME, Abd El-Ghany AA, Taha AI, Amin A. In vitro assessment of fracture resistance of endodontically treated teeth restored with short fiber reinforced resin based composite and ceramic overlays. BMC Oral Health. 2025 Feb 8;25(1):211. doi: 10.1186/s12903-025-05480-x.
PubMed 39922996Harp YS, Montaser MA, Zaghloul NM. Flowable fiber-reinforced versus flowable bulk-fill resin composites: Degree of conversion and microtensile bond strength to dentin in high C-factor cavities. J Esthet Restor Dent. 2022 Jun;34(4):699-706. doi: 10.1111/jerd.12901. Epub 2022 Mar 11.
PubMed 35274436
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
- ClinicalTrials.gov ID
- NCT07762651
- Acronym / sponsor ID
- Composite Restorations
- Conditions
- Dental Caries, Composite Resins, Composite Restoration
- Keywords
- Clinical, FDI criteria, Biodentin, Composite Restorations, Dentin Replacement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 27 Mar 2027 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 13 Aug 2026 (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 randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations.
Detailed description
Thirty patients ranging in age from 20 to 35 years will be enrolled into the study. This study will be designed as a randomized controlled clinical trial including patients requiring six Class I restorations. Participants will be randomly allocated into six groups according to the type of dentin replacement material used: Group I (Biodentin), Group II (Activa Bioactive), Group III (Glass ionomer cement), Group IV (Ever x posterior), and Group V (Flowable resin). Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical evaluation will be performed at baseline and 6, 12, and 18 months using modified FDI criteria, assessing retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and secondary caries. Data will be collected and statistically analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Other: BiodentineParticipants will receive posterior Class I composite restorations incorporating Biodentine as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| ACTIVA BioACTIVE | Experimental | Other: ACTIVA BioACTIVEParticipants will receive posterior Class I composite restorations incorporating ACTIVA BioACTIVE as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| Glass Ionomer Cement | Experimental | Other: glass ionomer cementParticipants will receive posterior Class I composite restorations incorporating conventional glass ionomer cement as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| everX Posterior | Experimental | Other: everX PosteriorParticipants will receive posterior Class I composite restorations incorporating everX Posterior as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| Flowable Resin | Experimental | Other: Flowable Resin CompositeParticipants will receive posterior Class I composite restorations incorporating flowable resin composite as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are medically able to undergo routine dental restorative treatment.
- Patients willing and able to provide written informed consent.
- Patients with adequate oral hygiene and periodontal health for participation in the study.
- Patients requiring posterior Class I restorations
Key exclusion criteria (4 listed)
- Patients with systemic conditions that contraindicate routine dental treatment.
- Patients unable or unwilling to provide informed consent.
- Patients with poor compliance or inability to attend scheduled follow-up visits.
- Teeth with clinical or radiographic evidence of irreversible pulpitis, pulp necrosis, or periapical pathology.
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 |
|---|---|---|
| BiodentineBiodentine will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions | Other | Biodentine |
| ACTIVA BioACTIVEACTIVA BioACTIVE will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions. | Other | ACTIVA BioACTIVE |
| glass ionomer cementGlass ionomer cement will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions. | Other | Glass Ionomer Cement |
| everX PosterioreverX Posterior will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions. | Other | everX Posterior |
| Flowable Resin CompositeFlowable resin composite will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions. | Other | Flowable Resin |
Primary outcome
marginal adaptation
Time frame: 18 months
Clinical evaluation of marginal adaptation was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was assessed and categorized according to the degree of conformity with the established criteria as follows: score 1, clinically excellent; scores 2 and 3, clinically satisfactory; and scores 4 and 5, clinically inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. Visual assessment was performed under adequate illumination using a high-intensity light source and a dental magnifying loupe to facilitate accurate evaluation. For statistical analysis, the Friedman test was used to assess within-group changes in restoration outcomes across the different follow-up periods. The Kruskal-Wallis test was applied to compare restoration outcomes among the different groups at each corresponding follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publication: PubMed 36307111Ahmed B, Hamama HH, Mahmoud SH. Microshear Bond Strength of Bioactive Materials to Dentin and Resin Composite. Eur J Dent. 2023 Jul;17(3):917-923. doi: 10.1055/s-0042-1756692. Epub 2022 Oct 28.
- Results publication: PubMed 36187866Karale R, Prathima BJ, Prashanth BR, Shivaranjan NS, Jain N. The effect of bulk-fill composites: Activa and Smart Dentin Replacement on cuspal deflection in endodontically treated teeth with different access cavity designs. J Conserv Dent. 2022 Jul-Aug;25(4):375-379. doi: 10.4103/jcd.jcd_53_22. Epub 2022 Aug 2.
- Results publication: PubMed 35656656Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
- Results publication: PubMed 39922996Hafez ME, Abd El-Ghany AA, Taha AI, Amin A. In vitro assessment of fracture resistance of endodontically treated teeth restored with short fiber reinforced resin based composite and ceramic overlays. BMC Oral Health. 2025 Feb 8;25(1):211. doi: 10.1186/s12903-025-05480-x.
- Results publication: PubMed 35274436Harp YS, Montaser MA, Zaghloul NM. Flowable fiber-reinforced versus flowable bulk-fill resin composites: Degree of conversion and microtensile bond strength to dentin in high C-factor cavities. J Esthet Restor Dent. 2022 Jun;34(4):699-706. doi: 10.1111/jerd.12901. Epub 2022 Mar 11.
- Individual participant dataSharing planned: No
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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.
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 Biodentine, ACTIVA BioACTIVE and glass ionomer cement in people with Dental Caries and Composite Resins, run by Tanta 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
marginal adaptation (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762651, which also lists 5 linked publications.
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 13 Aug 2026.