Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT

NCT07576673 | Not Yet Recruiting

• 1 other identifier: Self-cure Bulk fill Resin
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.

Conditions

Carious Cervical Lesions

Keywords

Class V; Cervical Carious Lesions; Self-cure Composite; Highly Filled Flowable Composite; Stela

Outcome Measures

Primary Outcomes (1)

• Retention

  The restoration will be clinically assessed according to the modified USPHS criteria. Restoration will be given Alpha score when there is no loss of restoration. It will be given a Charlie score when there is loss of restoration and need for replacement.

  18 Months

Secondary Outcomes (6)

• Marginal Adaptation

  18 months

• Marginal Discoloration

  18 months

• Post-operative Sensitivity

  18 months

• Recurrent Caries

  18 months

• Surface Roughness

  18 months

Study Arms (2)

Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia)

EXPERIMENTAL

Stela primer will be applied first after cavity preparation then Stela self-cure composite without curing.

Procedure: Class V Restoration

Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany)

ACTIVE COMPARATOR

After total etching of the cavity and bonding, the highly filled flowable composite will be applied in increments then cured.

Procedure: Class V Restoration

Interventions

Class V Restoration PROCEDURE

A class V cavity will be prepared after administering local anesthesia. Rubber dam isolation will be done followed by placement of the restorative material according to the randomization sequence.

Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany); Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients consulting in the outpatient clinic with cervical carious lesion.
• Age between 21-45 years.
• Males and females.

You may not qualify if:

• Systemic disease or severe medical complication.
• Allergy to any of the restorative materials.
• Pregnancy.
• Disabilities.
• Heavy smoking; xerostomia.
• Lack of compliance.
• Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
• Tooth-related Criteria:
• Small to moderate class V carious lesion.
• Teeth are vital with no signs of irreversible pulpitis.
• Caries cervical margins above the CEJ.
• Well-formed and fully erupted in normal functional occlusion with natural antagonist.
• Deciduous teeth; as the study is targeting only permanent teeth.
• Deep carious defects (close to the pulp, less than 1 mm distance).
• Tooth hypersensitivity.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Central Study Contacts

Abdelrahman Hamza, Bachelor of Science

CONTACT

+20 1063330630; abdelrahmanh.hamza@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Abdelrahman Hamza

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

EG (1)