Clinical Performance of Four Restorative Materials in Primary Molars

NCT07504393 | Not Yet Recruiting

• 1 other identifier: AAU-PEDO-1394-5575
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits

Conditions

Dental Caries; Primary Molars

Keywords

stela; Primary molars; Pediatric dentistry; Direct restoration; Cention N; Nanohybrid composite; Resin-modified glass ionomer; FDI criteria

Outcome Measures

Primary Outcomes (2)

• Restoration success based on FDI criteria (clinical and radiographic evaluation)

  6 months

• Restoration success based on FDI criteria (clinical and radiographic evaluation)

  Clinical and radiographic success of restorations assessed using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria (scores 1-5). Scores 1-3 are considered clinically acceptable; scores 4-5 are considered clinically unacceptable (repair or replacement indicated).

  6 months

Study Arms (4)

Group A: Cention N

EXPERIMENTAL

Device: Cention N

Group B: Stela (Self-cure Bulk-fill Composite)

EXPERIMENTAL

Device: Stela, SDI, Australia

Group C: Beautifil II (Nanohybrid Composite)

ACTIVE COMPARATOR

Device: Beautifil II, Shofu, Japan

Group D: Riva Light Cure (RMGIC)

ACTIVE COMPARATOR

Device: Resin modified glass ionomer cement

Interventions

Cention N DEVICE

Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Also known as: Ivoclar Vivadent

Group A: Cention N

Stela, SDI, Australia DEVICE

Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Group B: Stela (Self-cure Bulk-fill Composite)

Beautifil II, Shofu, Japan DEVICE

Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Group C: Beautifil II (Nanohybrid Composite)

Resin modified glass ionomer cement DEVICE

Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Group D: Riva Light Cure (RMGIC)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-8 years old.
• Primary molars indicated for restorative treatment.
• No pulp involvement or history of dental pain.
• Cooperative children (Frankl: +ve or ++ve).

You may not qualify if:

• Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
• Severe developmental enamel defects or insufficient enamel for bonding.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Hosam Hassan Metwalli

CONTACT

+201147957878; dr.hosamhassan2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment was performed by a blinded assessor who was unaware of group allocation; operator blinding was not feasible due to differences in material handling.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Four-arm, parallel-group randomized clinical trial (1:1:1:1).

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share