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

NCT07776912 | Recruiting

• 1 other identifier: 1021/3954
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  6 months post-restoration

Secondary Outcomes (2)

• Streptococcus Mutans Count

  6 months post-restoration

• Salivary pH Level

  6 months post-restoration

Study Arms (3)

Group A

EXPERIMENTAL

Primary molars with Class I cavity restoration using Cention-N material according to the manufacturer's instructions.

Device: Cention-N

Group B

EXPERIMENTAL

Primary molars with Class I cavity restoration using Zirconomer material according to the manufacturer's instructions

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

Device: Resin-Modified Glass Ionomer

Interventions

Cention-N DEVICE

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

Group A

Zirconomer DEVICE

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

Group B

Resin-Modified Glass Ionomer DEVICE

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

Group C

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galal Ali Mohamed Ebaid: lead

Study Sites (1)

Al-Azhar University (Faculty of Dentistry)

Cairo, 11651, Egypt

RECRUITING

Central Study Contacts

Galal A Elkady, B.Sc

CONTACT

00201001375178; dr_galal86@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: B.Sc. in Dental Medicine, Faculty of Dentistry, Al-Azhar University, Cairo, Egypt

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 20, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)