Streptococcus Mutans CountNCT07776912
Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars
A study testing Cention-N, Zirconomer and Resin-Modified Glass Ionomer in people with Streptococcus Mutans Count and Salivary pH, run by Galal Ali Mohamed Ebaid at 1 site in Egypt.
Trial summary
This study will evaluate the clinical performance, Streptococcus mutans count, and salivary pH for Cention-N, Zirconomer, and resin-modified glass ionomer in Class I restoration of primary molars. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Streptococcus Mutans Count, Salivary pH, Cention-N
- What is being tested?
- Cention-N, Zirconomer and Resin-Modified Glass Ionomer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 4-9 years.
- Children who have Class I lesions in both the maxillary and mandibular arches.
- Primary molar teeth had class I carious lesions in occlusal pits and fissures; the gap between intercuspal surfaces should not be exceeded during cavity preparation.
- Primary molars free of periapical pathosis.
- Primary molars free root resorption.
Who cannot join
- Primary molars with preapical pathosis or hypersensitivity.
- Primary molars with periodontal diseases or mobile molar tooth that indicated for extraction.
- Nonfunctioning teeth with no opposing dentition; heavy occlusion or signs of severe attrition; and endodontically treated teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University (Faculty of Dentistry)
Cairo, 11651
Galal A Elkady, B.Sc, 00201001375178, dr_galal86@yahoo.com
Adel F Hussein, MD
About this study
Official title: Evaluation of the Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars: A Randomized Clinical Trial
This study will evaluate the clinical performance, Streptococcus mutans count, and salivary pH for Cention-N, Zirconomer, and resin-modified glass ionomer in Class I restoration of primary molars.
Read the detailed description
A vital aspect of overall health is dental health. Recurrent effects of oral disease on eating, sleeping, working, and social duties are subtle and widespread, and they collectively form a hidden pandemic.
The most widely used substitute for amalgam is glass ionomer cement (GIC), which has recognized the capacity to produce fluoride and played a major role in their growing application in dentistry.
The components of resin-modified GICs (RMGIC) are the same as those of ordinary glass-ionomers: polyacid, water, and basic glass powder. A monomer component and related initiator system are also present. RMGICs were created when monomeric ingredients such as 2-hydroxyethyl methacrylate (HEMA), urethane dimethacrylate (UDMA), and bisphenol-A-glycidyl methacrylate (Bis-GMA) were added to the ionomer composition.
- Conditions
- Streptococcus Mutans Count, Salivary pH, Cention-N, Zirconomer, Resin-modified Glass Ionomer, Class I Restoration
- Being tested
- Cention-N, Zirconomer, Resin-Modified Glass Ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention-NDevice
Class I cavity restoration using Cention-N self-curing resin-based dental restorative material according to the manufacturer's instructions.
ZirconomerDevice
Class I cavity restoration using Zirconomer zirconia-reinforced glass ionomer restorative material according to the
Resin-Modified Glass IonomerDevice
Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) restorative material according to the manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Primary molars with Class I cavity restoration using Cention-N material according to the manufacturer's instructions. Receives: Device: Cention-N |
| Group B | Experimental | Primary molars with Class I cavity restoration using Zirconomer material according to the manufacturer's instructions Receives: Device: Zirconomer |
| Group C | Active comparator | Primary molars with Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) material according to the manufacturer's instructions Receives: Device: Resin-Modified Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of Restorations
Evaluation of the clinical performance of restorations using modified USPHS (FDI) criteria. It systematically grades how restorative materials (like composite resins, glass ionomers, and ceramics) perform in the mouth over time
Measured: 6 months post-restoration
Secondary outcomes (2)
Streptococcus Mutans Count
Assessment of Streptococcus mutans bacterial count in saliva/plaque samples expressed in CFU/mL will be recorded.
Measured: 6 months post-restoration
Salivary pH Level
Salivary pH changes will be measured using a digital pH meter.
Measured: 6 months post-restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Aug 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Mutans CountStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galal Ali Mohamed Ebaid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Galal Ali Mohamed Ebaid, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776912
- Sponsor's protocol ID
- 1021/3954
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07776912
- Acronym / sponsor ID
- 1021/3954
- Conditions
- Streptococcus Mutans Count, Salivary pH, Cention-N, Zirconomer, Resin-modified Glass Ionomer, Class I Restoration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Galal Ali Mohamed EbaidUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Aug 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 study will evaluate the clinical performance, Streptococcus mutans count, and salivary pH for Cention-N, Zirconomer, and resin-modified glass ionomer in Class I restoration of primary molars.
Detailed description
A vital aspect of overall health is dental health. Recurrent effects of oral disease on eating, sleeping, working, and social duties are subtle and widespread, and they collectively form a hidden pandemic.
The most widely used substitute for amalgam is glass ionomer cement (GIC), which has recognized the capacity to produce fluoride and played a major role in their growing application in dentistry.
The components of resin-modified GICs (RMGIC) are the same as those of ordinary glass-ionomers: polyacid, water, and basic glass powder. A monomer component and related initiator system are also present. RMGICs were created when monomeric ingredients such as 2-hydroxyethyl methacrylate (HEMA), urethane dimethacrylate (UDMA), and bisphenol-A-glycidyl methacrylate (Bis-GMA) were added to the ionomer composition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Cention-NPrimary molars with Class I cavity restoration using Cention-N material according to the manufacturer's instructions. |
| Group B | Experimental | Device: ZirconomerPrimary molars with Class I cavity restoration using Zirconomer material according to the manufacturer's instructions |
| Group C | Active comparator | Device: Resin-Modified Glass IonomerPrimary molars with Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) material according to the manufacturer's instructions |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 4-9 years.
- Children who have Class I lesions in both the maxillary and mandibular arches.
- Primary molar teeth had class I carious lesions in occlusal pits and fissures; the gap between intercuspal surfaces should not be exceeded during cavity preparation.
- Primary molars free of periapical pathosis.
- Primary molars free root resorption.
Key exclusion criteria (3 listed)
- Primary molars with preapical pathosis or hypersensitivity.
- Primary molars with periodontal diseases or mobile molar tooth that indicated for extraction.
- Nonfunctioning teeth with no opposing dentition; heavy occlusion or signs of severe attrition; and endodontically treated teeth.
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 |
|---|---|---|
| Cention-NClass I cavity restoration using Cention-N self-curing resin-based dental restorative material according to the manufacturer's instructions. | Device | Group A |
| ZirconomerClass I cavity restoration using Zirconomer zirconia-reinforced glass ionomer restorative material according to the | Device | Group B |
| Resin-Modified Glass IonomerClass I cavity restoration using Resin-Modified Glass Ionomer (RMGI) restorative material according to the manufacturer's instructions | Device | Group C |
Primary outcome
Clinical Performance of Restorations
Time frame: 6 months post-restoration
Evaluation of the clinical performance of restorations using modified USPHS (FDI) criteria. It systematically grades how restorative materials (like composite resins, glass ionomers, and ceramics) perform in the mouth over time
2 secondary outcomes
Streptococcus Mutans Count
Time frame: 6 months post-restoration
Salivary pH Level
Time frame: 6 months post-restoration
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 20 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cention-N, Zirconomer and Resin-Modified Glass Ionomer in people with Streptococcus Mutans Count and Salivary pH, run by Galal Ali Mohamed Ebaid 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: looking for participants now, as of the sponsor's last update on 20 Aug 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 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?
Contact Galal A Elkady, B.Sc (00201001375178, dr_galal86@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance of Restorations (time frame: 6 months post-restoration). 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 20 Aug 2026.