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

NCT07720999 | Completed DMC

• 1 other identifier: FDASU-Rec IM012564
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pre-heated composites; Pulpal inflammation; Gingival crevicular fluid; TNF-α; Postoperative pain; VAS; Randomized controlled trial; Resin composite preheating; Incremental composite placement; Deep carious lesions; GCF; ICDAS; Cytokine biomarkers; Dental restoration; VisCalor; Pulp-dentin complex; Endodontics

Outcome Measures

Primary Outcomes (1)

• Pulpal Inflammatory Response Assessed by Gingival Crevicular Fluid TNF-α Levels

  Changes in tumor necrosis factor-alpha (TNF-α) concentrations in gingival crevicular fluid (GCF) measured at three time points: baseline (pre-treatment), immediately post-restoration, and 7 days post-restoration. TNF-α is a key pro-inflammatory cytokine that reflects pulpal inflammatory status.

  Baseline (pre-treatment), immediately after restoration, and 7 days post-restoration

Secondary Outcomes (1)

• Postoperative Pain Assessed by Visual Analog Scale (VAS)

  Baseline (pre-treatment) and 7 days post-restoration

Study Arms (3)

Thermoviscous Bulk-Fill Composite - VisCalor (65°C)

EXPERIMENTAL

Participants in this arm will receive deep Class I restorations using thermoviscous bulk-fill composite (VisCalor, VOCO, Germany) preheated to 65°C using the VisCalor Dispenser. The composite is placed as a single 4-mm bulk increment and light-cured according to the manufacturer's instructions. GCF samples are collected at baseline, immediately post-treatment, and at 7-day follow-up for TNF-α quantification. Pain is assessed using VAS at baseline and day 7.

Device: Arm 1 only "VisCalor Thermoviscous Bulk-Fill Composite"

Preheated Conventional Nanohybrid Composite - 55°C

EXPERIMENTAL

Participants in this arm will receive deep Class I restorations using conventional nanohybrid composite (Tetric EvoCeram, Ivoclar Vivadent, Liechtenstein) preheated to 55°C using a Composite Heater (Cicada Dental, China). The composite is placed incrementally in 2-mm layers and light-cured according to the manufacturer's instructions. GCF samples are collected at baseline, immediately post-treatment, and at 7-day follow-up for TNF-α quantification. Pain is assessed using VAS at baseline and day 7.

Device: Tetric EvoCeram Conventional Nanohybrid Composite (Preheated 55°C)

Conventional Nanohybrid Composite - Room Temperature (Control)

EXPERIMENTAL

Participants in this arm will receive deep Class I restorations using conventional nanohybrid composite (Tetric EvoCeram, Ivoclar Vivadent, Liechtenstein) at room temperature (23°C) with no preheating. The composite is placed incrementally in 2-mm layers and light-cured according to the manufacturer's instructions. This arm serves as the control group. GCF samples are collected at baseline, immediately post-treatment, and at 7-day follow-up for TNF-α quantification. Pain is assessed using VAS at baseline and day 7.

Device: Tetric EvoCeram Conventional Nanohybrid Composite (Room Temperature)

Interventions

Arm 1 only "VisCalor Thermoviscous Bulk-Fill Composite" DEVICE

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.

Thermoviscous Bulk-Fill Composite - VisCalor (65°C)

Tetric EvoCeram Conventional Nanohybrid Composite (Preheated 55°C) DEVICE

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.

Preheated Conventional Nanohybrid Composite - 55°C

Tetric EvoCeram Conventional Nanohybrid Composite (Room Temperature) DEVICE

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.

Conventional Nanohybrid Composite - Room Temperature (Control)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 years in good general health
• Asymptomatic deep occlusal carious lesions with ICDAS scores 5 and 6, confirmed by preoperative periapical radiographs
• Healthy gingiva with probing depths ≤ 3 mm
• Normal occlusion
• No radiographic evidence of periodontal bone loss
• No anti-inflammatory or antibiotic therapy within the preceding six months
• Willingness to provide written informed consent and complete the full study period

You may not qualify if:

• Pregnant or nursing women
• Incarcerated individuals
• Individuals with mental health disorders
• Current tobacco users
• Patients with systemic conditions (e.g., diabetes mellitus, immunocompromise)
• Teeth with prior endodontic therapy
• Periodontal pockets \>3 mm
• Use of medications influencing inflammatory responses
• Orthodontic appliance wearers
• History of allergy to dental materials or local anesthetics
• Active periodontal disease
• Teeth with periapical pathology or pulp exposure

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (6)

• Tauböck TT, Tarle Z, Marovic D, Attin T, Attin R. Pre-heating of resin composites: Effects on conversion, mechanical properties and polymerization shrinkage. Dent Mater. 2015;31(8):895-902.

  BACKGROUND

• Dawson VS, Amjad S, Fransson H. Endodontic complications in teeth with vital pulps restored with composite resins: a systematic review. Int Endod J. 2015 Jul;48(7):627-38. doi: 10.1111/iej.12364. Epub 2014 Sep 12.

  PMID: 25100025 BACKGROUND

• Morrison JI, Borg P, Simon A. Plasticity and recovery of skeletal muscle satellite cells during limb regeneration. FASEB J. 2010 Mar;24(3):750-6. doi: 10.1096/fj.09-134825. Epub 2009 Nov 3.

  PMID: 19887652 BACKGROUND

• Pezelj-Ribaric S, Anic I, Brekalo I, Miletic I, Hasan M, Simunovic-Soskic M. Detection of tumor necrosis factor alpha in normal and inflamed human dental pulps. Arch Med Res. 2002 Sep-Oct;33(5):482-4. doi: 10.1016/s0188-4409(02)00396-x.

  PMID: 12459320 BACKGROUND

• ZACH L, COHEN G. PULP RESPONSE TO EXTERNALLY APPLIED HEAT. Oral Surg Oral Med Oral Pathol. 1965 Apr;19:515-30. doi: 10.1016/0030-4220(65)90015-0. No abstract available.

  PMID: 14263662 BACKGROUND

• Celik N, Askin S, Gul MA, Seven N. The effect of restorative materials on cytokines in gingival crevicular fluid. Arch Oral Biol. 2017 Dec;84:139-144. doi: 10.1016/j.archoralbio.2017.09.026. Epub 2017 Sep 27.

  PMID: 28992599 BACKGROUND

Related Links

• The official website of the Faculty of Dentistry, Ain Shams University, where the study was conducted.
• The CONSORT guidelines used for reporting this randomized controlled trial.
• The ethical guidelines followed in conducting this study.

MeSH Terms

Conditions

Dental Caries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this single-blinded study, the outcome assessor is masked to group allocation. The assessor responsible for GCF sample collection, ELISA analysis, and pain score evaluation has no knowledge of which intervention each participant received. The operator who performs the restorative procedures cannot be masked due to the nature of the preheating protocols (different devices and temperatures). Participants are not informed of their group assignment to minimize expectation bias. The allocation sequence is concealed in sequentially numbered, sealed, opaque envelopes, and the assessor does not have access to the randomization list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel-group, randomized controlled trial with three arms. Participants are allocated to one of three groups in a 1:1:1 ratio. Group I receives thermoviscous bulk-fill composite preheated to 65°C placed as a single 4-mm increment. Group II receives conventional nanohybrid composite preheated to 55°C placed incrementally. Group III (control) receives conventional nanohybrid composite at room temperature (23°C) placed incrementally. All participants are followed for 7 days post-treatment with GCF collection and pain assessment at designated timepoints. No crossover between groups occurs.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: November 1, 2025
• Primary Completion: May 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)