Secondary CariesBARMNCT07619378
Effect of Bioactive Restorative Materials on Secondary Caries Prevention
A study testing Fuji IX GP Glass Ionomer Cement, Beautifil II Giomer and Cention N in people with Secondary Caries, run by Jouf University at 1 site in Saudi Arabia.
Trial summary
This manuscript presents a 24-month randomised clinical trial evaluating the effectiveness of bioactive restorative materials in preventing secondary caries compared with conventional composite restorations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries
- What is being tested?
- Fuji IX GP Glass Ionomer Cement, Beautifil II Giomer and Cention N
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2023to 1 May 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
- Adults aged 18-55 years
- Presence of at least one primary Class I or Class II cavity in a permanent posterior tooth
- High caries risk with DMFT score ≥ 4 according to the Cariogram assessment
- Presence of at least 20 functional teeth
- Good general health
- Ability and willingness to attend follow-up and recall visits
Who cannot join
- Pregnant women
- Patients undergoing current orthodontic treatment
- Presence of severe periodontitis
- Xerostomia
- Known allergy to any restorative material component used in the study
- Bruxism or parafunctional habits
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Jouf University
Sakakah, Aljouf, 72388
About this study
Official title: Effect of Bioactive Restorative Materials on Secondary Caries Prevention: A 24-month Randomized Clinical Trial
This manuscript presents a 24-month randomised clinical trial evaluating the effectiveness of bioactive restorative materials in preventing secondary caries compared with conventional composite restorations. Four restorative materials were tested in 120 class I and II cavities among high-caries-risk adults: conventional composite (Filtek Z350 XT), glass ionomer cement (Fuji IX GP), giomer (Beautifil II), and Cention N.
- Conditions
- Secondary Caries
- Being tested
- Fuji IX GP Glass Ionomer Cement, Beautifil II Giomer, Cention N, Filtek Z350 XT Composite Resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuji IX GP Glass Ionomer CementDevice
Fuji IX GP Glass Ionomer Cement
Beautifil II GiomerDevice
Beautifil II Giomer
Cention NDevice
Cention N
Filtek Z350 XT Composite ResinDevice
Filtek Z350 XT Composite Resin
| Study group | Role | What they receive |
|---|---|---|
| Conventional resin composite restorations | Active comparator | Arm 1 - Composite (Control): Participants received restorations using Filtek Z350 XT nano-filled resin composite placed according to the manufacturer's instructions following minimally invasive cavity preparation. Receives: Device: Fuji IX GP Glass Ionomer Cement; Device: Beautifil II Giomer; Device: Cention N |
| Glass Ionomer Cement (GIC) | Experimental | Arm 2 - Glass Ionomer Cement (GIC): Participants received restorations using Fuji IX GP conventional glass ionomer cement with fluoride-releasing properties. Receives: Device: Beautifil II Giomer; Device: Cention N; Device: Filtek Z350 XT Composite Resin |
| Giomer | Active comparator | Arm 3 - Giomer: Participants received restorations using Beautifil II giomer restorative material containing surface pre-reacted glass ionomer (S-PRG) fillers capable of releasing and recharging bioactive ions. Receives: Device: Fuji IX GP Glass Ionomer Cement; Device: Cention N; Device: Filtek Z350 XT Composite Resin |
| Cention N | Experimental | Cention N: Participants received restorations using Cention N alkasite restorative material containing alkaline glass fillers designed to release calcium, hydroxide, and fluoride ions under acidic conditions. Receives: Device: Fuji IX GP Glass Ionomer Cement; Device: Beautifil II Giomer; Device: Filtek Z350 XT Composite Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Number of Restorations Developing Secondary Caries. Secondary caries will be assessed using the International Caries Detection and Assessment System (ICDAS-II), with any score ≥3 at the cavosurface margin considered indicative of secondary caries. Evaluations will be performed at baseline, 6, 12, and 24 months.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 May 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary CariesStudies 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Meshal Alonazi, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619378
- Sponsor's protocol ID
- 1-02-45
- Acronym
- BARM
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be made available by the corresponding author upon reasonable request
Publications
1.Kassebaum NJ, Smith AGC, Bernabé E, Fleming TD, Reynolds AE, Vos T, et al. Global, regional, and national prevalence, incidence, and disability-adjusted life years for oral conditions for 195 countries, 1990-2015. J Dent Res. 2017;96(4):380-387. doi:10.1177/0022034517693566. 2.Peres MA, Macpherson LMD, Weyant RJ, Daly B, Venturelli R, Mathur MR, et al. Oral diseases: a global public health challenge. Lancet. 2019;394(10194):249-260. doi:10.1016/S0140-6736(19)31146-8. 3.Demarco FF, Corrêa MB, Cenci MS, Moraes RR, Opdam NJM. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28(1):87-101. doi:10.1016/j.dental.2011.09.003. 4.Opdam NJM, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93(10):943-949. doi:10.1177/0022034514544217. 5.Mjör IA, Toffenetti F. Secondary caries: a literature review with case reports. Quintessence Int. 2000;31(3):165-179. 6.Eltahlah D, Lynch CD, Chadwick BL, Blum IR, Wilson NHF. An update on the reasons for placement and replacement of direct restorations. J Dent. 2018;72:1-7. doi:10.1016/j.jdent.2018.03.001. 7.Kopperud SE, Tveit AB, Gaarden T, Sandvik L, Espelid I. Longevity of posterior dental restorations and reasons for failure. Eur J Oral Sci. 2012;120(6):539-548. doi:10.1111/eos.12004. 8.Nedeljkovic I, Teughels W, De Munck J, Van Meerbeek B, Van Landuyt KL. Is secondary caries with composites a material-based problem? Dent Mater. 2015;31(11):e247-e277. doi:10.1016/j.dental.2015.09.001. 9.Kidd EAM. Diagnosis of secondary caries. J Dent Educ. 2001;65(10):997-1000. doi:10.1002/j.0022-0337.2001.65.10.tb03459.x. 10.Ferracane JL. Resin composite-state of the art. Dent Mater. 2011;27(1):29-38. doi:10.1016/j.dental.2010.10.020. 11.Schwendicke F, Tu YK, Hsu LY, Göstemeyer G. Antibacterial effects of cavity lining materials in caries-affected dentine: a systematic review. Cari
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioactive Restorative Materials on Secondary Caries Prevention: A 24-month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07619378
- Acronym / sponsor ID
- BARM / 1-02-45
- Conditions
- Secondary Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 2 Jun 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 manuscript presents a 24-month randomised clinical trial evaluating the effectiveness of bioactive restorative materials in preventing secondary caries compared with conventional composite restorations. Four restorative materials were tested in 120 class I and II cavities among high-caries-risk adults: conventional composite (Filtek Z350 XT), glass ionomer cement (Fuji IX GP), giomer (Beautifil II), and Cention N.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional resin composite restorations | Active comparator | Device: Fuji IX GP Glass Ionomer Cement, Device: Beautifil II Giomer, Device: Cention NArm 1 - Composite (Control): Participants received restorations using Filtek Z350 XT nano-filled resin composite placed according to the manufacturer's instructions following minimally invasive cavity preparation. |
| Glass Ionomer Cement (GIC) | Experimental | Device: Beautifil II Giomer, Device: Cention N, Device: Filtek Z350 XT Composite ResinArm 2 - Glass Ionomer Cement (GIC): Participants received restorations using Fuji IX GP conventional glass ionomer cement with fluoride-releasing properties. |
| Giomer | Active comparator | Device: Fuji IX GP Glass Ionomer Cement, Device: Cention N, Device: Filtek Z350 XT Composite ResinArm 3 - Giomer: Participants received restorations using Beautifil II giomer restorative material containing surface pre-reacted glass ionomer (S-PRG) fillers capable of releasing and recharging bioactive ions. |
| Cention N | Experimental | Device: Fuji IX GP Glass Ionomer Cement, Device: Beautifil II Giomer, Device: Filtek Z350 XT Composite ResinCention N: Participants received restorations using Cention N alkasite restorative material containing alkaline glass fillers designed to release calcium, hydroxide, and fluoride ions under acidic conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-55 years
- Presence of at least one primary Class I or Class II cavity in a permanent posterior tooth
- High caries risk with DMFT score ≥ 4 according to the Cariogram assessment
- Presence of at least 20 functional teeth
- Good general health
Key exclusion criteria (6 listed)
- Pregnant women
- Patients undergoing current orthodontic treatment
- Presence of severe periodontitis
- Xerostomia
- Known allergy to any restorative material component used in the study
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 |
|---|---|---|
| Fuji IX GP Glass Ionomer CementFuji IX GP Glass Ionomer Cement | Device | Cention N, Conventional resin composite restorations, Giomer |
| Beautifil II GiomerBeautifil II Giomer | Device | Cention N, Conventional resin composite restorations, Glass Ionomer Cement (GIC) |
| Cention NCention N | Device | Conventional resin composite restorations, Giomer, Glass Ionomer Cement (GIC) |
| Filtek Z350 XT Composite ResinFiltek Z350 XT Composite Resin | Device | Cention N, Giomer, Glass Ionomer Cement (GIC) |
Primary outcome
Primary outcome measure
Time frame: 2 years
Number of Restorations Developing Secondary Caries. Secondary caries will be assessed using the International Caries Detection and Assessment System (ICDAS-II), with any score ≥3 at the cavosurface margin considered indicative of secondary caries. Evaluations will be performed at baseline, 6, 12, and 24 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 2 Jun 2026.
- Background1.Kassebaum NJ, Smith AGC, Bernabé E, Fleming TD, Reynolds AE, Vos T, et al. Global, regional, and national prevalence, incidence, and disability-adjusted life years for oral conditions for 195 countries, 1990-2015. J Dent Res. 2017;96(4):380-387. doi:10.1177/0022034517693566. 2.Peres MA, Macpherson LMD, Weyant RJ, Daly B, Venturelli R, Mathur MR, et al. Oral diseases: a global public health challenge. Lancet. 2019;394(10194):249-260. doi:10.1016/S0140-6736(19)31146-8. 3.Demarco FF, Corrêa MB, Cenci MS, Moraes RR, Opdam NJM. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28(1):87-101. doi:10.1016/j.dental.2011.09.003. 4.Opdam NJM, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, et al. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014;93(10):943-949. doi:10.1177/0022034514544217. 5.Mjör IA, Toffenetti F. Secondary caries: a literature review with case reports. Quintessence Int. 2000;31(3):165-179. 6.Eltahlah D, Lynch CD, Chadwick BL, Blum IR, Wilson NHF. An update on the reasons for placement and replacement of direct restorations. J Dent. 2018;72:1-7. doi:10.1016/j.jdent.2018.03.001. 7.Kopperud SE, Tveit AB, Gaarden T, Sandvik L, Espelid I. Longevity of posterior dental restorations and reasons for failure. Eur J Oral Sci. 2012;120(6):539-548. doi:10.1111/eos.12004. 8.Nedeljkovic I, Teughels W, De Munck J, Van Meerbeek B, Van Landuyt KL. Is secondary caries with composites a material-based problem? Dent Mater. 2015;31(11):e247-e277. doi:10.1016/j.dental.2015.09.001. 9.Kidd EAM. Diagnosis of secondary caries. J Dent Educ. 2001;65(10):997-1000. doi:10.1002/j.0022-0337.2001.65.10.tb03459.x. 10.Ferracane JL. Resin composite-state of the art. Dent Mater. 2011;27(1):29-38. doi:10.1016/j.dental.2010.10.020. 11.Schwendicke F, Tu YK, Hsu LY, Göstemeyer G. Antibacterial effects of cavity lining materials in caries-affected dentine: a systematic review. Cari
- Individual participant dataSharing planned: No. De-identified data may be made available by the corresponding author upon reasonable request
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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 Fuji IX GP Glass Ionomer Cement, Beautifil II Giomer and Cention N in people with Secondary Caries, run by Jouf University at 1 site in Saudi Arabia.
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 6 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 2 Jun 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 Saudi Arabia. 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?
Primary outcome measure (time frame: 2 years). 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 NCT07619378, which also lists 1 linked publication.
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 2 Jun 2026.