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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

ConditionsStreptococcus Mutans CountSalivary pHCention-NZirconomerResin-modified Glass IonomerClass I RestorationPrimary Molars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorGalal Ali Mohamed Ebaid

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months post-restoration

Secondary outcomes

1

Streptococcus Mutans Count

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

Time frame
6 months post-restoration
2

Salivary pH Level

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

Time frame
6 months post-restoration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Galal Ali Mohamed Ebaid

Lead sponsor

Al-Azhar University

Sponsor institution

Source ClinicalTrials.gov
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