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Not yet recruiting NCT07576673

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

No phase Interventional Carious Cervical Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Class V Restoration - Polofil, Class V Restoration - Stela.
Who it may be relevant to
Registry conditions: Carious Cervical Lesions. Basic parameters: 21 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial

Overview

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.

Detailed description

Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.

For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.

Interventions

  • Procedure 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 th
  • Procedure 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 pol

Primary outcome measures

  • Retention [Time frame: 18 Months]
Secondary outcome measures (6)
  • Marginal Adaptation [Time frame: 18 months]
  • Marginal Discoloration [Time frame: 18 months]
  • Post-operative Sensitivity [Time frame: 18 months]
  • Recurrent Caries [Time frame: 18 months]
  • Surface Roughness [Time frame: 18 months]
  • Color Match [Time frame: 18 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT07576673 · Self-cure Bulk fill Resin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗