Clinical Evaluation of Self- Adhesive Bulk-fill Resin Composite Versus Conventionally Bonded Bulk-fill Resin Composite in Restoration of Proximal Lesions

NCT04888676 | Unknown DMC

• 1 other identifier: cons21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to evaluate and compare the clinical performance of Self- Adhesive Bulk fill Resin Composite Versus Conventionally Bonded Bulk fill resin composite in Restoration of Proximal Lesions Over a Period of 18 months Follow-up 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 Advanced Self- Adhesive bulk-fill Resin Composite. (Surefil one™ ,Dentsupply Sirona) in increments of 3-4mm,For the control group: The sectional matrix will be applied first , followed by filling of cavity with bulk-fill resin composite material (GrandioSO x-tra® bulk) in increments of 3-4mm,Clinical evaluation will be done using using USPHS criteria at 6,12 and 18 months follow up.

Conditions

Dental Caries Class II

Outcome Measures

Primary Outcomes (5)

• Fracture

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

  18 months

• Marginal adaptation

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

  18 months

• Anatomic form

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

  18 months

• Surface roughness

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

  18 months

• Retention

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

  18 months

Secondary Outcomes (2)

• Postoperative sensitivity

  18 months

• secondary caries

  18 months

Study Arms (2)

Self- Adhesive Bulk fill Resin Composite ( Surefil one™ ,Dentsupply Sirona)

EXPERIMENTAL

New Surefil one™ restorative Self-adhesive: no etching, bonding or cavity conditioning inserted in increments of up to 4 mm in thickness.

Procedure: Class II Restoration

Bulkfill Resin Composite. (Tetric N-Ceram Bulk Fill )

ACTIVE COMPARATOR

after selective etching of enamel and bonding, the bulk-fill composite resins are inserted in increments of up to 4 mm in thickness.

Procedure: Class II Restoration

Interventions

Class II Restoration PROCEDURE

A Class II cavity will be prepared after local anesthesia has been given as required.Rubber dam isolation will be done.Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.followed by filling of cavity in increments of 3-4mm

Bulkfill Resin Composite. (Tetric N-Ceram Bulk Fill ); Self- Adhesive Bulk fill Resin Composite ( Surefil one™ ,Dentsupply Sirona)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient-related 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.
• Tooth related criteria:
• Teeth with primary proximal carious lesions .
• Teeth are vital according to pulp-sensitivity tests.

You may not qualify if:

• Patient-related 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:
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Mohamed sabry Mohamed

Cairo, Nasr City, 11311, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants Participants will be blinded to the technique used, since the patient will attend the same number of visits and he can not differentiate between different restorative materials. Blinding of the operator The operator cannot be blinded because of the use of different restorative materials applied in each group. The outcome assessor The outcome assessor will be blinded to the material used. This will be performed by M.A. and Y.H. Therefore it is necessary that the assessors won't be included in the preclinical assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant lecturer at Conservative department.

Model Details: Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: June 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: May 15, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 24 months
• Access Criteria: open access

Locations

EG (1)