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

NCT07576673 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

  • Carious Cervical Lesions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-02-28
Completion
2027-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07576673 on ClinicalTrials.gov