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

NCT07720999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • Pulpal Inflammation
  • Dental Caries
  • Postoperative Pain

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-05-30
Completion
2026-06-30

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 NCT07720999 on ClinicalTrials.gov