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COMPLETED
NCT07720999
NA

Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlled Trial)

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial evaluates the effect of different resin composite preheating protocols on pulpal inflammation and postoperative pain. Thirty patients with deep occlusal carious lesions (ICDAS scores 5 and 6) will be randomly assigned to three equal groups (n=10). Group I will receive thermoviscous bulk-fill composite (VisCalor, VOCO) preheated to 65°C and placed as a single 4-mm increment. Group II will receive conventional nanohybrid composite (Ivoclar Vivadent) preheated to 55°C and placed incrementally. Group III (control) will receive the same composite at room temperature (23°C) using incremental placement. Gingival crevicular fluid (GCF) samples will be collected at baseline, immediately post-treatment, and at 7-day follow-up. Tumor necrosis factor-alpha (TNF-α) concentrations will be quantified using ELISA. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at baseline and day 7. The study aims to determine whether different preheating protocols differentially affect pulpal inflammatory status and whether GCF TNF-α correlates with postoperative pain.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-11-01

Completion Date

2026-06-30

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DEVICE

Arm 1 only "VisCalor Thermoviscous Bulk-Fill Composite"

VisCalor (VOCO, Germany) is a thermoviscous bulk-fill composite resin designed for posterior restorations. It is supplied in compules and preheated to 65°C using the VisCalor Dispenser, which maintains the material at the target temperature until the moment of application. The composite has 89% filled universal nano-hybrid composition and is placed as a single 4-mm bulk increment.

DEVICE

Tetric EvoCeram Conventional Nanohybrid Composite (Preheated 55°C)

Tetric EvoCeram (Ivoclar Vivadent, Liechtenstein) is a conventional nanohybrid composite resin with 76 wt.% filler content (barium glass, ytterbium trifluoride, silicon dioxide, mixed oxide). It is preheated to 55°C using a Composite Heater (Cicada Dental, China) for 5 minutes and placed incrementally in 2-mm layers. Each increment is light-cured for 20 seconds.

DEVICE

Tetric EvoCeram Conventional Nanohybrid Composite (Room Temperature)

Tetric EvoCeram (Ivoclar Vivadent, Liechtenstein) is a conventional nanohybrid composite resin with 76 wt.% filler content (barium glass, ytterbium trifluoride, silicon dioxide, mixed oxide). It is used at room temperature (23°C) without preheating and placed incrementally in 2-mm layers. Each increment is light-cured for 20 seconds. This is the control intervention.

Locations (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt