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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • class II restoration

    Procedure/Surgery

    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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Self- Cure Bulk fill Resin Composite (Stela Automix or Stela Capsule, SDI Ltd, Australia)Experimental treatment 1 intervention
Group B: Bulk-fill Resin Composite. (Tetric N-Ceram Bulk Fill, Liechtenstein)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Marginal adaptation

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.

Time frame
24 months

Secondary outcomes

1

Marginal discoloration

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.

Time frame
24 months
2

Recurrent caries

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.

Time frame
24 months
3

Retention analysis

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.

Time frame
24 months
4

Surface roughness

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: