Class I Cavities in High Caries RiskNCT06924047
The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)
A study testing Beautifil Flow Plus X and EverX Flow in people with Class I Cavities in High Caries Risk and Class I Composite Restorations, run by Dalia Sameh Fawzi.
Trial summary
Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Class I Cavities in High Caries Risk, Class I Composite Restorations, Randomized Clinical Trial
- What is being tested?
- Beautifil Flow Plus X and EverX Flow
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged (20-50)
- Medically free
- Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
- Patients accepting to participate in the study.
- Teeth of normal appearance and morphology
- Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.
Who cannot join
- Patients <20 and >50.
- Teeth with proximal lesions.
- Patients with bad oral hygiene (Plaque index >2).
- Systematic disease that may interfere with the study.
- Patients with xerostomia.
- Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
Show all 12Show fewer
- Patients undergoing or will start orthodontic treatment.
- Pregnancy.
- Teeth with signs or symptoms of irreversible pulpitis.
- Non-vital, fractured or cracked teeth.
- Teeth with secondary caries.
- Periodontally compromised teeth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial
Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.
- Conditions
- Class I Cavities in High Caries Risk, Class I Composite Restorations, Randomized Clinical Trial, Occlusal Caries, Fiber Reinforced Composite, Injectable Composite
- Being tested
- Beautifil Flow Plus X, EverX Flow
- Keywords
- occlusal caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil Flow Plus XOther
Shofu's Beautifil Flow Plus X F00 a advanced bioactive injectable composite
EverX FlowOther
Short fiber reinforced composite
| Study group | Role | What they receive |
|---|---|---|
| Bioactive injectable composite | Active comparator | bioactive injectable composite placed as a dentine substitute Receives: Other: Beautifil Flow Plus X |
| Short fiber reinforced composite | Active comparator | Short fiber reinforced composite added as a dentine substitute Receives: Other: EverX Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
- Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying.
- Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying
- Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying
- Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention
- Clinically poor (entirely insufficient): Generalized severe deficiencies
Measured: T1: 1 week T2: 6months T3: 12 months
Secondary outcomes (2)
Recurrent caries
- Clinically excellent/very good (sufficient): No caries/demineralization at the restoration margin detectable after air drying.
- Clinically good (sufficient): First visible signs of a non-cavitated caries lesion at the restoration margin detectable after air drying.
- Clinically satisfactory (sufficient): Established, non- cavitated caries lesion or microcavity at the restoration margin detectable without air drying.
- Clinically unsatisfactory (partially insufficient): Localized dentin cavity at the restoration margin.
- Clinically poor (entirely insufficient): Extensive dentin cavity at the restoration margin.
Measured: T1: 1 week T2: 6months T3: 12 months
Post operative sensitivity
- Clinically excellent/very good (sufficient): No Postoperative hypersensitivity.
- Clinically good (sufficient): Minor postoperative hypersensitivity.
- Clinically satisfactory (sufficient) Distinct "moderate" postoperative hypersensitivity.
- Clinically unsatisfactory (partially insufficient): Severe "persistent" postoperative hypersensitivity.
- Clinically poor (entirely insufficient): Extreme postoperative hypersensitivity "Irreversible pulpitis".
Measured: T1: 1 week T2: 6months T3: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Class I Cavities in High Caries RiskStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Sameh Fawzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Sameh Fawzi, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924047
- Sponsor's protocol ID
- Restoring Deep Occlusal Cavity
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schwendicke F, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona AF, Innes NP. Managing Carious Lesions: Consensus Recommendations on Carious Tissue Removal. Adv Dent Res. 2016 May;28(2):58-67. doi: 10.1177/0022034516639271.
PubMed 27099358Yao Y, Luo A, Hao Y. Selective versus stepwise removal of deep carious lesions: A meta-analysis of randomized controlled trials. J Dent Sci. 2023 Jan;18(1):17-26. doi: 10.1016/j.jds.2022.07.021. Epub 2022 Aug 21.
PubMed 36643250Rusnac ME, Gasparik C, Irimie AI, Grecu AG, Mesaros AS, Dudea D. Giomers in dentistry - at the boundary between dental composites and glass-ionomers. Med Pharm Rep. 2019 Apr;92(2):123-128. doi: 10.15386/mpr-1169. Epub 2019 Apr 25.
PubMed 31086838Reis A, Carrilho M, Breschi L, Loguercio AD. Overview of clinical alternatives to minimize the degradation of the resin-dentin bonds. Oper Dent. 2013 Jul-Aug;38(4):E1-E25. doi: 10.2341/12-258-LIT. Epub 2013 Mar 25.
PubMed 23527523Qin D, Hua F, John MT. GLOSSARY FOR DENTAL PATIENT-CENTERED OUTCOMES. J Evid Based Dent Pract. 2024 Jan;24(1S):101951. doi: 10.1016/j.jebdp.2023.101951. Epub 2023 Nov 5.
PubMed 38401954Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.
PubMed 35934807Maillet C, Decup F, Dantony E, Iwaz J, Chevalier C, Gueyffier F, Maucort-Boulch D, Grosgogeat B, Le Clerc J. Selected and simplified FDI criteria for assessment of restorations. J Dent. 2022 Jul;122:104109. doi: 10.1016/j.jdent.2022.104109. Epub 2022 Mar 26.
PubMed 35346772Ikeda I, Otsuki M, Sadr A, Nomura T, Kishikawa R, Tagami J. Effect of filler content of flowable composites on resin-cavity interface. Dent Mater J. 2009 Nov;28(6):679-85. doi: 10.4012/dmj.28.679.
PubMed 20019418Hoefler V, Nagaoka H, Miller CS. Long-term survival and vitality outcomes of permanent teeth following deep caries treatment with step-wise and partial-caries-removal: A Systematic Review. J Dent. 2016 Nov;54:25-32. doi: 10.1016/j.jdent.2016.09.009. Epub 2016 Sep 21.
PubMed 27664467Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.
PubMed 39653674ElAziz RHA, ElAziz SAA, ElAziz PMA, Frater M, Vallittu PK, Lassila L, Garoushi S. Clinical evaluation of posterior flowable short fiber-reinforced composite restorations without proximal surface coverage. Odontology. 2024 Oct;112(4):1274-1283. doi: 10.1007/s10266-024-00905-5. Epub 2024 Feb 23.
PubMed 38393515European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
PubMed 30664240Bijelic-Donova J, Myyrylainen T, Karsila V, Vallittu PK, Tanner J. Direct Short-Fiber Reinforced Composite Resin Restorations and Glass-Ceramic Endocrowns in Endodontically Treated Molars: A 4 -Year Clinical Study. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):284-295. doi: 10.1922/EJPRD_2333Bijelic-Donova12.
PubMed 35438265Battancs E, Sary T, Molnar J, Braunitzer G, Skolnikovics M, Schindler A, Szabo P B, Garoushi S, Frater M. Fracture Resistance and Microleakage around Direct Restorations in High C-Factor Cavities. Polymers (Basel). 2022 Aug 25;14(17):3463. doi: 10.3390/polym14173463.
PubMed 36080538
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06924047
- Acronym / sponsor ID
- Restoring Deep Occlusal Cavity
- Conditions
- Class I Cavities in High Caries Risk, Class I Composite Restorations, Randomized Clinical Trial, Occlusal Caries, Fiber Reinforced Composite, Injectable Composite
- Keywords
- occlusal caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dalia Sameh FawziUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive injectable composite | Active comparator | Other: Beautifil Flow Plus Xbioactive injectable composite placed as a dentine substitute |
| Short fiber reinforced composite | Active comparator | Other: EverX FlowShort fiber reinforced composite added as a dentine substitute |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients aged (20-50)
- Medically free
- Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
- Patients accepting to participate in the study.
- Teeth of normal appearance and morphology
Key exclusion criteria (12 listed)
- Patients <20 and >50.
- Teeth with proximal lesions.
- Patients with bad oral hygiene (Plaque index >2).
- Systematic disease that may interfere with the study.
- Patients with xerostomia.
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 |
|---|---|---|
| Beautifil Flow Plus XShofu's Beautifil Flow Plus X F00 a advanced bioactive injectable composite | Other | Bioactive injectable composite |
| EverX FlowShort fiber reinforced composite | Other | Short fiber reinforced composite |
Primary outcome
Fracture
Time frame: T1: 1 week T2: 6months T3: 12 months
1. Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying. 2. Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying 3. Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying 4. Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention 5. Clinically poor (entirely insufficient): Generalized severe deficiencies
2 secondary outcomes
Recurrent caries
Time frame: T1: 1 week T2: 6months T3: 12 months
Post operative sensitivity
Time frame: T1: 1 week T2: 6months T3: 12 months
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 11 Apr 2025.
- Background: PubMed 27099358Schwendicke F, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona AF, Innes NP. Managing Carious Lesions: Consensus Recommendations on Carious Tissue Removal. Adv Dent Res. 2016 May;28(2):58-67. doi: 10.1177/0022034516639271.
- Results publication: PubMed 36643250Yao Y, Luo A, Hao Y. Selective versus stepwise removal of deep carious lesions: A meta-analysis of randomized controlled trials. J Dent Sci. 2023 Jan;18(1):17-26. doi: 10.1016/j.jds.2022.07.021. Epub 2022 Aug 21.
- Results publication: PubMed 31086838Rusnac ME, Gasparik C, Irimie AI, Grecu AG, Mesaros AS, Dudea D. Giomers in dentistry - at the boundary between dental composites and glass-ionomers. Med Pharm Rep. 2019 Apr;92(2):123-128. doi: 10.15386/mpr-1169. Epub 2019 Apr 25.
- Results publication: PubMed 23527523Reis A, Carrilho M, Breschi L, Loguercio AD. Overview of clinical alternatives to minimize the degradation of the resin-dentin bonds. Oper Dent. 2013 Jul-Aug;38(4):E1-E25. doi: 10.2341/12-258-LIT. Epub 2013 Mar 25.
- Results publication: PubMed 38401954Qin D, Hua F, John MT. GLOSSARY FOR DENTAL PATIENT-CENTERED OUTCOMES. J Evid Based Dent Pract. 2024 Jan;24(1S):101951. doi: 10.1016/j.jebdp.2023.101951. Epub 2023 Nov 5.
- Results publication: PubMed 35934807Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.
- Results publication: PubMed 35346772Maillet C, Decup F, Dantony E, Iwaz J, Chevalier C, Gueyffier F, Maucort-Boulch D, Grosgogeat B, Le Clerc J. Selected and simplified FDI criteria for assessment of restorations. J Dent. 2022 Jul;122:104109. doi: 10.1016/j.jdent.2022.104109. Epub 2022 Mar 26.
- Results publication: PubMed 20019418Ikeda I, Otsuki M, Sadr A, Nomura T, Kishikawa R, Tagami J. Effect of filler content of flowable composites on resin-cavity interface. Dent Mater J. 2009 Nov;28(6):679-85. doi: 10.4012/dmj.28.679.
- Results publication: PubMed 27664467Hoefler V, Nagaoka H, Miller CS. Long-term survival and vitality outcomes of permanent teeth following deep caries treatment with step-wise and partial-caries-removal: A Systematic Review. J Dent. 2016 Nov;54:25-32. doi: 10.1016/j.jdent.2016.09.009. Epub 2016 Sep 21.
- Results publication: PubMed 39653674Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.
- Results publication: PubMed 38393515ElAziz RHA, ElAziz SAA, ElAziz PMA, Frater M, Vallittu PK, Lassila L, Garoushi S. Clinical evaluation of posterior flowable short fiber-reinforced composite restorations without proximal surface coverage. Odontology. 2024 Oct;112(4):1274-1283. doi: 10.1007/s10266-024-00905-5. Epub 2024 Feb 23.
- Results publication: PubMed 30664240European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
Related trials for Class I Cavities in High Caries Risk
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.
Questions about this trial
What is this clinical trial studying?
A study testing Beautifil Flow Plus X and EverX Flow in people with Class I Cavities in High Caries Risk and Class I Composite Restorations, run by Dalia Sameh Fawzi.
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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dalia SA Fawzi, BDS (+201147984047, dr.daliasameh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: T1: 1 week T2: 6months T3: 12 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 NCT06924047, which also lists 14 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 11 Apr 2025.