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Clinical Trials in Egypt / NCT07576673
Starting soon Not applicable

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

NCT07576673 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Not applicable
Started
2026-12
Last updated
2026-11-10

Condition(s) studied

Carious Cervical Lesions

Investigational drug(s) / intervention(s)

Class V Restoration - PolofilClass V Restoration - Stela

Class V Restoration - Polofil: A class V cavity with 1 mm occlusal bevel will be prepared after administering local anesthesia. Rubber dam isolation will be done, , etching of the enamel (20-30 seconds) and dentin (15 seconds) using a 35% phosphoric acid etch (Kulzer Gluma Etch, Kulzer GmbH, Germany), then rinsing for 20 seconds followed by controlled drying of the cavity till it's slightly moist. Application of the bonding agent (Solobond M, Voco GmbH, Germany) using a disposable brush and leaving it to act for 30 seconds then an air jet will be used to disperse the bonding agent. Curing for 20 seconds will be done using a LED light curing unit with curing intensity 1200-3000 mw/cm2 (CuringPen-E, Changzhou Sifary Medical Technology Co., Ltd, China). Flowable composite (Polofil NHT flow, Voco GmbH, Germany) will be placed, adapted by gold plated applicator then light polymerized for 20 seconds using light emitting diode (LED) light curing unit.

Class V Restoration - Stela: A class V cavity with 1 mm occlusal bevel will be prepared after administrating local anesthesia followed by rubber dam isolation. Stela Primer (SDI Limited, Australia.) will be applied for 5 seconds on the cavity and the margins, then it will be gently dried with air for 2-3 seconds without light curing. The self-cure bulk fill resin composite (Stela Automix or Stela Capsule, SDI Limited, Australia) will be applied then sculpted using a gold-plated composite applicator (Lascod, Italy). Full polymerization will take place after 4 minutes.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
45 Years
Healthy volunteers
No
Patient-related Criteria: A) Inclusion Criteria: * Patients consulting in the outpatient clinic with cervical carious lesion. * Age between 21-45 years. * Males and females. B) Exclusion Criteria: * 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: A) Inclusion 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. B) Exclusion Criteria: * Deciduous teeth; as the study is targeting only permanent teeth. * Deep carious defects (close to the pulp, less than 1 mm distance). * Tooth hypersensitivity. * Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries). * Heavy occlusion and occlusal contacts or history of bruxism. * Endodontically treated teeth. * Periapical pathology or signs of pulpal pathology.

Primary outcome measure(s)

  • Retention — 18 Months
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry, Cairo University Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07576673 on ClinicalTrials.gov ↗ ← All trials in Egypt