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NCT Number: NCT07576673

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

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.

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Key information

Conditions

Carious Cervical Lesions

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Class V Restoration - Polofil

Procedure

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

Procedure

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.

Primary outcomes

  1. Retention

    Time frame: 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.

Secondary outcomes

  1. Marginal Adaptation

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when the restoration is closely adapted with no detectable margin. It will be given a Bravo score when there is a detectable marginal discrepancy, but it still clinically acceptable. It will be given a Charlie score when there is a marginal crevice that is clinically unacceptable.

  2. Marginal Discoloration

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no discoloration between the tooth and the restoration. It will be given a Bravo score when there is superficial discoloration which can be polished away. It will be give a Charlie score when the discoloration has penetrated beyond the margin in pulpal direction.

  3. Post-operative Sensitivity

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when there is no post-operative sensitivity and a Charlie score when there is post-operative sensitivity.

  4. Recurrent Caries

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no detectable recurrent caries and a Charlie score when recurrent caries is detected.

  5. Surface Roughness

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no surface defect. It will be given a bravo score when there is minimal surface defect. It will be given a charlie score when there is a severe surface defect.

  6. Color Match

    Time frame: 18 months

    The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when the restoration matches the color of the tooth. It will be give a Bravo score when there is an acceptable mismatch. It will be given a Charlie score when there is an unacceptable mismatch.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Hamza, Bachelor of Science

CONTACT

[email protected]

+20 1063330630

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.