Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlle… (NCT07720999) | Clinical Trial Compass
CompletedNot Applicable
Effect of Different Heating Protocols of Resin Composites on Pulp Condition (Randomized Controlled Trial)
Egypt30 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulpal Inflammatory Response Assessed by Gingival Crevicular Fluid TNF-α Levels
Timeframe: Baseline (pre-treatment), immediately after restoration, and 7 days post-restoration