NCT04888676进行中（未招募）不适用

Clinical Evaluation 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: A Randomized Clinical Trial

Cairo University2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2021年6月15日最近更新: 2022年10月18日

研究概览

简要总结

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.

详细描述

A) Participants, interventions & outcomes 9. Study setting Study will be conducted in the Conservative Dentistry Department, Faculty of Dentistry - Cairo University.

Eligibility criteria 10.a.1 Inclusion criteria:

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:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.