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Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07776912
Enrollment
45
Registered
2026-08-20
Start date
2025-08-01
Completion date
2027-12-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cention-N, Class I Restoration, Primary Molars, Resin-modified Glass Ionomer, Salivary pH, Streptococcus Mutans Count, Zirconomer

Brief 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.

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.

Interventions

DEVICECention-N

Class I cavity restoration using Cention-N self-curing resin-based dental restorative material according to the manufacturer's instructions.

Class I cavity restoration using Zirconomer zirconia-reinforced glass ionomer restorative material according to the

Class I cavity restoration using Resin-Modified Glass Ionomer (RMGI) restorative material according to the manufacturer's instructions

Sponsors

Galal Ali Mohamed Ebaid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Performance of Restorations6 months post-restorationEvaluation 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

Secondary

MeasureTime frameDescription
Streptococcus Mutans Count6 months post-restorationAssessment of Streptococcus mutans bacterial count in saliva/plaque samples expressed in CFU/mL will be recorded.
Salivary pH Level6 months post-restorationSalivary pH changes will be measured using a digital pH meter.

Countries

Egypt

Contacts

CONTACTGalal A Elkady, B.Sc
dr_galal86@yahoo.com00201001375178

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026