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NCT Number: NCT07776912

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

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University (Faculty of Dentistry)

Cairo, 11651, Egypt

Location status: Recruiting

Location contact

Adel F Hussein, MD

SUB_INVESTIGATOR

Galal A Elkady, B.Sc

CONTACT

[email protected]

00201001375178

Waleed O Kadour, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cention-N

Device

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

Zirconomer

Device

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

Resin-Modified Glass Ionomer

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Streptococcus Mutans Count

    Time frame: 6 months post-restoration

    Assessment of Streptococcus mutans bacterial count in saliva/plaque samples expressed in CFU/mL will be recorded.

  2. Salivary pH Level

    Time frame: 6 months post-restoration

    Salivary pH changes will be measured using a digital pH meter.

Study contacts

Contact information is provided by the study sponsor or research team.

Galal A Elkady, B.Sc

CONTACT

[email protected]

00201001375178

Sponsors and collaborators

Lead sponsor

Galal Ali Mohamed Ebaid

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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