ClinicalTrials.gg
Enrolling by invitationNCT07762651Updated Aug 13, 2026

Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations

An interventional study of Biodentine and ACTIVA BioACTIVE in Dental Caries, Composite Resins and Composite Restoration, sponsored by Tanta University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Aug 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 205 studies in Dental Caries with a site in Egypt — 47 open to participants now, 67 under way, 1 of them phase 3. Dental Caries · Egypt.

Planned enrollment
128th of 179
30 · median 44
Started
2025
with 31 others
No phase
153 of 205
36 open now
Primary completion
2027-03
later than 56 of 66 live
Registered
198th of 205
by date

Among the 205 studies in Dental Caries with a site in Egypt, this one is the 128th largest by planned enrollment of the 179 interventional ones that give a count, is one of 32 that started in 2025, is one of 153 with no phase, reaches primary completion later than 56 of the 66 other live ones, and was the 198th registered.

Dental Caries

1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.

Browse Dental Caries studies →

Open to participants now

47 of the 205 studies in Dental Caries with a site in Egypt are open now. Recruiting first, the newest first:

42 more — sign in →

All 47 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.

This study: 25 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 205 studies in Dental Caries with a site in Egypt, or all of them as a file.
02

Study 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 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

03

Conditions studied

  • Dental Caries
  • Composite Resins
  • Composite Restoration

Browse trials for

Keywords

  • Clinical
  • FDI criteria
  • Biodentin
  • Composite Restorations
  • Dentin Replacement
04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are medically able to undergo routine dental restorative treatment.
  • Patients willing and able to provide written .
  • Patients with adequate oral hygiene and periodontal health for participation in the study.
  • Patients requiring posterior Class I restorations

Exclusion criteria

Exclusion Criteria:

  • Patients with systemic conditions that contraindicate routine dental treatment.
  • Patients unable or unwilling to provide .
  • 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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Biodentine

    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.

    Other: Biodentine

  • Experimental
    ACTIVA BioACTIVE

    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.

    Other: ACTIVA BioACTIVE

  • Experimental
    Glass Ionomer Cement

    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.

    Other: glass ionomer cement

  • Experimental
    everX Posterior

    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.

    Other: everX Posterior

  • Experimental
    Flowable Resin

    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

    Other: Flowable Resin Composite

Interventions

  • OtherBiodentine

    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

  • OtherACTIVA BioACTIVE

    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.

  • Otherglass ionomer cement

    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.

  • OthereverX Posterior

    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.

  • OtherFlowable Resin Composite

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

07

Study locations

1 site
08

References and documents

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 36307111 ↗
  • Karale 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 36187866 ↗
  • Choudhury 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 35656656 ↗
  • Hafez 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 39922996 ↗
  • Harp 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.

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 planned 19 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.

Registered
Aug 8, 2026
First posted
Aug 13, 2026
StartActual
Aug 12, 2025
Primary completionEst.
Mar 27, 2027
CompletionEst.
Mar 29, 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762651
Lead sponsor
Tanta University
Responsible party
Mohammed Abd El Ghany Mohammed (Principal Investigator, Tanta University) — Principal investigator
First posted
Aug 13, 2026
Start date
Aug 12, 2025
Primary completion
Mar 27, 2027 (estimated)
Completion
Mar 29, 2027 (estimated)
Last update
Aug 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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