Class I Dental CariesNCT07003360
Clinical Evaluation of Bioactive Restorative Materials
A study testing application of beautiful blukfill II shofu composite, application of Ivoclar vivadent bulkfill composite and application of Predicta bulk fill composite in people with Class I Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
The objectives of this study are to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Dental Caries
- What is being tested?
- application of beautiful blukfill II shofu composite, application of Ivoclar vivadent bulkfill composite and application of Predicta bulk fill composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2025to 30 Dec 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with four primary occlusal caries of upper or lower posterior teeth.
- Patients must have a good oral hygiene;
- Patients with tooth gives a positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- • High caries risk patients with extremely poor oral hygiene
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University, Egypt
Al Mansurah, Dakahliya, Egypt,, 35516
About this study
Official title: Biofilm Inhibition and Remineralizing Potential of Bioactive Restorative Materials: Two-Year Randomized Clinical Trial in Class I Cavities
The objectives of this study are to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.
Read the detailed description
This study will be intended to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.
Null hypothesis This study will be designed to test the null hypothesis that there will be no significant difference in neither biofilm inhibition nor remineralizing potential at tooth-restoration interface of the used tested materials. Also, that there will be no significant difference in the 2-year clinical outcomes of the bioactive restorative materials in class I cavities.
Sample size calculation was based on clinical performance according to FDI criteria between different bioactive restorative materials that was retrieved from previous research.19 Using G power program version 3.1.9.7 to calculate sample size, using 2-tailed test, α error =0.05 and power = 80%, the total calculated sample size will be 30 cases at least in each group Patient selection The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.
Study Design:
The total number of patients will be 30 patients. Each patient will receive restorative materials studied in this investigation.
Clinical procedures All restorations will be done by a single experienced operator and with proper magnification aids. The restorative procedures will be performed under local anesthesia and rubber dam isolation. Cavity preparations for resin composite restoration will be prepared using high speed handpiece.
Evaluation procedures All restorations will be clinically evaluated immediately after finishing and polishing (baseline), 6 months, 12 months, 18 months and finally after 24 months by two independent examiners. If any restoration failed, repair or replacement of the restoration will be considered.
- Conditions
- Class I Dental Caries
- Being tested
- application of beautiful blukfill II shofu composite, application of Ivoclar vivadent bulkfill composite, application of Predicta bulk fill composite, application of Stela self-cure bulk fill composite
- Keywords
- class I dental caries, bioactive materials, biofilm inhibition, remineralizing potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of beautiful blukfill II shofu compositeProcedure or surgery
Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, beautiful bluk fill II composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.
application of Ivoclar vivadent bulkfill compositeProcedure or surgery
Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.
application of Predicta bulk fill compositeProcedure or surgery
Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed
application of Stela self-cure bulk fill compositeProcedure or surgery
Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Stela self-cure bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.
| Study group | Role | What they receive |
|---|---|---|
| application of beautiful blukfill II shofu composite | Active comparator | Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece . Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.
cavities without a liner, beautiful blukfill II shofu composite were placed in bulk (a maximum 4mm thickness layer) with manual filling instruments and burnishers and cured for 40 seconds. Occlusal adjustments were performed using fine grit yellow-coded tapered with round ends and flame-shaped diamond stones (Komet, USA).
Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. Receives: Procedure: application of beautiful blukfill II shofu composite |
| application of Ivoclar vivadent bulkfill composite | Active comparator | Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.
cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).
Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. Receives: Procedure: application of Ivoclar vivadent bulkfill composite |
| application of Predicta bulk fill composite | Active comparator | Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.
cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).
Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. Receives: Procedure: application of Predicta bulk fill composite |
| application of Stela self-cure bulk fill composite | Active comparator | Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.
cavities without a liner, Stela self-cure bulk fill composite placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds , Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).
Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. Receives: Procedure: application of Stela self-cure bulk fill composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypersensitivity/pulp status
Postoperative hypersensitivity/pulp status.The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria
- Intensity was assessed with Visual Analogue Scale. Postoperative sensitivity was evaluated by blowing a stream of compressed air for 3 seconds at a distance of 2-3 cm from the restoration. -Vitality was tested with application of cold (dry ice) and compared the reaction with the adjacent vital teeth . This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Measured: Two years after restoration
Marginal adaptation
The marginal adaptation will be evaluated through visual examination using a - A magnifying aid (loupe 4.5 x) was used for evaluation. Two special probes with different blunt tips (150 and 250 μm). This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1- 3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Measured: Two years after restoration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start2 Mar 2025
- Primary completion2 Nov 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I Dental CariesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003360
- Sponsor's protocol ID
- M0202025CD
- Status last verified
- Feb 2025
- First submitted
- 12 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm Inhibition and Remineralizing Potential of Bioactive Restorative Materials: Two-Year Randomized Clinical Trial in Class I Cavities
- ClinicalTrials.gov ID
- NCT07003360
- Acronym / sponsor ID
- M0202025CD
- Conditions
- Class I Dental Caries
- Keywords
- class I dental caries, bioactive materials, biofilm inhibition, remineralizing potential
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Jun 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.
The objectives of this study are to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.
Detailed description
This study will be intended to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.
Null hypothesis This study will be designed to test the null hypothesis that there will be no significant difference in neither biofilm inhibition nor remineralizing potential at tooth-restoration interface of the used tested materials. Also, that there will be no significant difference in the 2-year clinical outcomes of the bioactive restorative materials in class I cavities.
Sample size calculation was based on clinical performance according to FDI criteria between different bioactive restorative materials that was retrieved from previous research.19 Using G power program version 3.1.9.7 to calculate sample size, using 2-tailed test, α error =0.05 and power = 80%, the total calculated sample size will be 30 cases at least in each group Patient selection The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.
Study Design:
The total number of patients will be 30 patients. Each patient will receive restorative materials studied in this investigation.
Clinical procedures All restorations will be done by a single experienced operator and with proper magnification aids. The restorative procedures will be performed under local anesthesia and rubber dam isolation. Cavity preparations for resin composite restoration will be prepared using high speed handpiece.
Evaluation procedures All restorations will be clinically evaluated immediately after finishing and polishing (baseline), 6 months, 12 months, 18 months and finally after 24 months by two independent examiners. If any restoration failed, repair or replacement of the restoration will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| application of beautiful blukfill II shofu composite | Active comparator | Procedure: application of beautiful blukfill II shofu compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece . Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations. cavities without a liner, beautiful blukfill II shofu composite were placed in bulk (a maximum 4mm thickness layer) with manual filling instruments and burnishers and cured for 40 seconds. Occlusal adjustments were performed using fine grit yellow-coded tapered with round ends and flame-shaped diamond stones (Komet, USA). Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. |
| application of Ivoclar vivadent bulkfill composite | Active comparator | Procedure: application of Ivoclar vivadent bulkfill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations. cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA). Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. |
| application of Predicta bulk fill composite | Active comparator | Procedure: application of Predicta bulk fill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations. cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA). Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. |
| application of Stela self-cure bulk fill composite | Active comparator | Procedure: application of Stela self-cure bulk fill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations. cavities without a liner, Stela self-cure bulk fill composite placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds , Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA). Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with four primary occlusal caries of upper or lower posterior teeth.
Key exclusion criteria (3 listed)
- • High caries risk patients with extremely poor oral hygiene
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 |
|---|---|---|
| application of beautiful blukfill II shofu compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, beautiful bluk fill II composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed. | Procedure or surgery | application of beautiful blukfill II shofu composite |
| application of Ivoclar vivadent bulkfill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed. | Procedure or surgery | application of Ivoclar vivadent bulkfill composite |
| application of Predicta bulk fill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed | Procedure or surgery | application of Predicta bulk fill composite |
| application of Stela self-cure bulk fill compositeOperative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Stela self-cure bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed. | Procedure or surgery | application of Stela self-cure bulk fill composite |
Primary outcome
Postoperative hypersensitivity/pulp status
Time frame: Two years after restoration
Postoperative hypersensitivity/pulp status.The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria - Intensity was assessed with Visual Analogue Scale. Postoperative sensitivity was evaluated by blowing a stream of compressed air for 3 seconds at a distance of 2-3 cm from the restoration. -Vitality was tested with application of cold (dry ice) and compared the reaction with the adjacent vital teeth . This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Marginal adaptation
Time frame: Two years after restoration]
The marginal adaptation will be evaluated through visual examination using a - A magnifying aid (loupe 4.5 x) was used for evaluation. Two special probes with different blunt tips (150 and 250 μm). This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1- 3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
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 4 Jun 2025.
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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 application of beautiful blukfill II shofu composite, application of Ivoclar vivadent bulkfill composite and application of Predicta bulk fill composite in people with Class I Dental Caries, run by Mansoura 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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?
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?
Postoperative hypersensitivity/pulp status (time frame: Two years after restoration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.