Dental CariesNCT05466461
Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities
A study testing Beautifil Flow Plus X. and Activa bioactive restorative in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Beautifil Flow Plus X. and Activa bioactive restorative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18 to 55 years.
- Male or female patients.
- Patients with no history of allergic reactions to methacrylate compounds and in good general health.
- Patients with good general health.
- Patients with good recall availability. Patients required Class V restoration
- Vital teeth with normal appearance and morphology.
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- Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure.
- Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and/or abnormal tooth mobility .
- No defects and lesions for other operative intervention, occlusal and proximal contacts with adjacent teeth.
Who cannot join
- Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation.
- Pregnant and lactating females.
- Any patients with medical and/or dental histories which could possibly complicate the provision of the proposed restoration and/or influence behavior and performance of the restorations in clinical service.
- They are included in the evaluation of other restorative materials and systems involving the anterior and/or posterior teeth.
- Patients who maintain an unacceptable standard of oral hygiene.
- Teeth with noncarious cervical lesions.
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- Severe tooth sensitivity.
- Non-vital or fracture or cracked teeth.
- Tooth with defective restoration.
- Teeth with advanced periodontal diseases.
- There is evidence occlusal parafunctions and/or atypical tooth wear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Injectable Flowable Composite With Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities (A Randomized Clinical Trial)
This study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
Read the detailed description
Bioactive glass has an amorphous structure, whereas glass-ceramics are crystallized glasses and composites of a crystalline phase in a residual glassy phase. Bioactive glass consists solely of the elements found in the body material, mainly being silicon (Si), calcium (Ca), sodium (Na), phosphorous (P), and oxygen (O) . Among the diverse kinds of bioactive glass filler, surface pre- reacted glass ionomer (S-PRG) filler has already been used for a relatively long time in some specific commercial RBCs. Most studies investigating this material assortment have focused on ion-release degree and potentially associated antibacterial effects. The restoration's surface integrity may be a key factor determining the eventual clinical beneficial effect of the alleged antibacterial properties. The antibacterial efficacy of bioactive glass depends on the concentration of the ions released from the glass.
As inorganic bioactive fillers, S-PRGs have the additional ability to release ions. S-PRG filler is considered a multifunctional bioactive glass because it can release several types of ions including Al, B, F, Na, Si, and Sr. The released ions can exhibit a variety of bioactive behaviors, such as preventing fungal and bacterial adhesion, antibacterial activity, neutralizing acids, inhibiting demineralization, and enhancing remineralization.
The biological effects of S-PRG fillers have been studied for several types of oral pathogens. It was reported that the elute of the S-PRG filler has a protective effect against Streptococcus mutans. Moreover, the elute of S-PRG filler reduced the density and thickness of the formed biofilm.
- Conditions
- Dental Caries
- Being tested
- Beautifil Flow Plus X., Activa bioactive restorative
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil Flow Plus X.Procedure or surgery
Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel.Single Bond TM Universal will be applied to cavity walls and margins with agitation for 20 seconds.The adhesive will be light-cured for 20 seconds. Then Beautifil Flow Plus X composite will be placed
Activa bioactive restorativeProcedure or surgery
Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel. Bonding agent will be applied on the entire cavity and light-cured for 20 seconds then Activa bioactive restorative composite will be applied and cured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Beautifil Flow Plus X. | Experimental | Giomers is a hybrid material category which contains Surface Pre-Reacted Glass-ionomer filler or S-PRG filler is produced from fluoroboro-alumino-silicate glass and polyacrylic acid through an acid-base reaction to form a stable glass ionomer phase on glass filler particle surfaces. S-PRG fillers can release and recharge fluoride. Also, the S-PRG filler-containing resinous materials are able to release various ions, such as aluminum (Al3+), boron (BO3 3-), fluoride (F- ), sodium (Na+), silicon (SiO3 2-), and strontium (Sr2+), in neutral and acidic conditions. Receives: Procedure: Beautifil Flow Plus X. |
| Activa bioactive restorative | Active comparator | Activa BioACTIVE Restorative (Activa), developed by Pulpdent (Watertown, MA, USA), is a new bioactive restorative material that combines the advantages of an RMGIC (resin modified glass ionomer cement) and RBC (resin based composite), representing a new category of restorative materials that are ion releasing. It contains methacrylate- based monomers, a modified polyacrylic acid, modified Diurethane Dimethacrylate (rubberized resin), and fillers Receives: Procedure: Activa bioactive restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
Alfa: there is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure.
Bravo: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has not penetrated along the restoration in a pulpal direction.
Charlie: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has penetrated along the restoration in a pulpal direction.
Measured: Change between baseline,6 months and 12 months
Secondary outcomes (1)
Assessment of Modified USPHS criteria. (Secondary caries) change over time
Alfa: no caries is present. Charlie: caries is present.
Measured: Change between baseline,6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jun 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- Model description
- Compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) over one year through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassma Reda Abdelhafeez, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466461
- Sponsor's protocol ID
- 236756
- Status last verified
- May 2025
- First submitted
- 15 Jul 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoshihara K, Nagaoka N, Maruo Y, Sano H, Yoshida Y, Van Meerbeek B. Bacterial adhesion not inhibited by ion-releasing bioactive glass filler. Dent Mater. 2017 Jun;33(6):723-734. doi: 10.1016/j.dental.2017.04.002. Epub 2017 Apr 29.
PubMed 28465066Nomura R, Morita Y, Matayoshi S, Nakano K. Inhibitory effect of surface pre-reacted glass-ionomer (S-PRG) eluate against adhesion and colonization by Streptococcus mutans. Sci Rep. 2018 Mar 22;8(1):5056. doi: 10.1038/s41598-018-23354-x.
PubMed 29568011Tonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue Conditioner Incorporating a Nano-Sized Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler. Materials (Basel). 2021 Nov 4;14(21):6648. doi: 10.3390/ma14216648.
PubMed 34772173
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Injectable Flowable Composite With Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05466461
- Acronym / sponsor ID
- 236756
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 20 Jul 2022 (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 study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
Detailed description
Bioactive glass has an amorphous structure, whereas glass-ceramics are crystallized glasses and composites of a crystalline phase in a residual glassy phase. Bioactive glass consists solely of the elements found in the body material, mainly being silicon (Si), calcium (Ca), sodium (Na), phosphorous (P), and oxygen (O) . Among the diverse kinds of bioactive glass filler, surface pre- reacted glass ionomer (S-PRG) filler has already been used for a relatively long time in some specific commercial RBCs. Most studies investigating this material assortment have focused on ion-release degree and potentially associated antibacterial effects. The restoration's surface integrity may be a key factor determining the eventual clinical beneficial effect of the alleged antibacterial properties. The antibacterial efficacy of bioactive glass depends on the concentration of the ions released from the glass.
As inorganic bioactive fillers, S-PRGs have the additional ability to release ions. S-PRG filler is considered a multifunctional bioactive glass because it can release several types of ions including Al, B, F, Na, Si, and Sr. The released ions can exhibit a variety of bioactive behaviors, such as preventing fungal and bacterial adhesion, antibacterial activity, neutralizing acids, inhibiting demineralization, and enhancing remineralization.
The biological effects of S-PRG fillers have been studied for several types of oral pathogens. It was reported that the elute of the S-PRG filler has a protective effect against Streptococcus mutans. Moreover, the elute of S-PRG filler reduced the density and thickness of the formed biofilm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) over one year through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
| Arm | Type | Receives |
|---|---|---|
| Beautifil Flow Plus X. | Experimental | Procedure: Beautifil Flow Plus X.Giomers is a hybrid material category which contains Surface Pre-Reacted Glass-ionomer filler or S-PRG filler is produced from fluoroboro-alumino-silicate glass and polyacrylic acid through an acid-base reaction to form a stable glass ionomer phase on glass filler particle surfaces. S-PRG fillers can release and recharge fluoride. Also, the S-PRG filler-containing resinous materials are able to release various ions, such as aluminum (Al3+), boron (BO3 3-), fluoride (F- ), sodium (Na+), silicon (SiO3 2-), and strontium (Sr2+), in neutral and acidic conditions. |
| Activa bioactive restorative | Active comparator | Procedure: Activa bioactive restorativeActiva BioACTIVE Restorative (Activa), developed by Pulpdent (Watertown, MA, USA), is a new bioactive restorative material that combines the advantages of an RMGIC (resin modified glass ionomer cement) and RBC (resin based composite), representing a new category of restorative materials that are ion releasing. It contains methacrylate- based monomers, a modified polyacrylic acid, modified Diurethane Dimethacrylate (rubberized resin), and fillers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- ages 18 to 55 years.
- Male or female patients.
- Patients with no history of allergic reactions to methacrylate compounds and in good general health.
- Patients with good general health.
- Patients with good recall availability. Patients required Class V restoration
Key exclusion criteria (11 listed)
- Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation.
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 X.Class V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel.Single Bond TM Universal will be applied to cavity walls and margins with agitation for 20 seconds.The adhesive will be light-cured for 20 seconds. Then Beautifil Flow Plus X composite will be placed | Procedure or surgery | Beautifil Flow Plus X. |
| Activa bioactive restorativeClass V cavities will be prepared, Selective etching technique will be used with phosphoric acid etching gel for 15 seconds on enamel. Bonding agent will be applied on the entire cavity and light-cured for 20 seconds then Activa bioactive restorative composite will be applied and cured for 20 seconds. | Procedure or surgery | Activa bioactive restorative |
Primary outcome
Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
Time frame: Change between baseline,6 months and 12 months
Alfa: there is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has not penetrated along the restoration in a pulpal direction. Charlie: there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has penetrated along the restoration in a pulpal direction.
1 secondary outcome
Assessment of Modified USPHS criteria. (Secondary caries) change over time
Time frame: Change between baseline,6 months and 12 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 21 May 2025.
- Background: PubMed 28465066Yoshihara K, Nagaoka N, Maruo Y, Sano H, Yoshida Y, Van Meerbeek B. Bacterial adhesion not inhibited by ion-releasing bioactive glass filler. Dent Mater. 2017 Jun;33(6):723-734. doi: 10.1016/j.dental.2017.04.002. Epub 2017 Apr 29.
- Background: PubMed 29568011Nomura R, Morita Y, Matayoshi S, Nakano K. Inhibitory effect of surface pre-reacted glass-ionomer (S-PRG) eluate against adhesion and colonization by Streptococcus mutans. Sci Rep. 2018 Mar 22;8(1):5056. doi: 10.1038/s41598-018-23354-x.
- Background: PubMed 34772173Tonprasong W, Inokoshi M, Tamura M, Uo M, Wada T, Takahashi R, Hatano K, Shimizubata M, Minakuchi S. Tissue Conditioner Incorporating a Nano-Sized Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler. Materials (Basel). 2021 Nov 4;14(21):6648. doi: 10.3390/ma14216648.
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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. 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 Beautifil Flow Plus X. and Activa bioactive restorative in people with Dental Caries, 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 9 inclusion and 11 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 21 May 2025. 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?
Assessment of Modified USPHS Criteria (Marginal discoloration) change over time (time frame: Change between baseline,6 months and 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 NCT05466461, which also lists 3 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 21 May 2025.