Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT06859086

Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite

the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence.

For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up

Who can participate

Healthy volunteers accepted: No

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

Patient-related criteria:

Inclusion criteria

  • Patients consulting in one of the outpatient clinics listed above.
  • Able to tolerate necessary restorative procedures.
  • Provide informed consent.
  • Accepts the 18 months follow-up period.

Exclusion criteria

  • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
  • Pregnant women; as radiographs cannot be taken for them.
  • Allergy to any of the restorative materials, including anesthetics.
  • Uncooperative patients, will not abide by the instructions or attend the appointments.

Tooth related criteria:

Inclusion criteria

  • Teeth with primary proximal carious lesions.
  • Teeth are vital according to pulp-sensitivity tests.
  • Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.

Exclusion criteria

  • Deciduous teeth; as the study is targeting only permanent teeth.
  • Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
  • Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
  • Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
  • Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
  • Teeth with cervical caries; which can't be evaluated on periapical radiographs.

Treatment and study plan

class II restoration

Procedure

A class II cavity will be prepared after local anesthesia has been given as requierd . Rubber dam isolation will be done. Sectional matricing and wedging will be done. Followed by placement of restorative material according to the randomization sequence.

Primary outcomes

  1. Marginal adaptation

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

Secondary outcomes

  1. Marginal discoloration

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

  2. Recurrent caries

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.

  3. Retention analysis

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.

  4. Surface roughness

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

  5. Postoperative sensitivity

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.

  6. Anatomic form

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

  7. Proximal contact

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

  8. Color match

    Time frame: 24 months

    The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

Study contacts

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

Wafaa Marei Kakat, Master Degree

CONTACT

[email protected]

00201554054804

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite in Restoration of Proximal Lesions Over a Period Of 24 Months Follow-Up: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

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.

Published trials that share one or more normalized conditions with this study.