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NOT YET RECRUITING
NCT07576673
NA

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

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

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.

Official 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

Key Details

Gender

All

Age Range

21 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09

Completion Date

2027-04

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

PROCEDURE

Class V Restoration - Polofil

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.

PROCEDURE

Class V Restoration - Stela

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.

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt