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NCT Number: NCT07694661

Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)

The goal of this clinical trial is to evalute the effect of different resin composite packing techniques on pulpal condition in patient with deep carious occlusal cavities in their molar teeth. The main questions it aims to answer are:

* Do composite packing technquies cause pulpal inflammatory response ? * Do composite packing technquies cause post operative pain ? Researchers will compare elastic cavity liner packing techniques to sonic activated and flowable bulk packing techniques to see their effect on pulp condition.

Participants will :

* Provide an honest medial and dental history to undergo the restorative procedures . * Report subjective symptons. * Attend all scheduled follow-ups visit for pulp assessment.

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Key information

Conditions

Deep Carious Lesion Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain shams university

Giza, 3235142, Egypt

About this study

This clinical study evaluates the impact of various resin composite packing techniques on pulp inflammation and post-operative condition, specifically comparing the biological and mechanical outcomes of incremental layering of packable composite with flowable liner versus modern bulk-fill strategies as SoniFill bulk fill resin composite and SDR bulk fill composite. The research involves preparing standardized cavities in clinical participants and restoring them using specialized resin materials to determine how different application methods influence polymerization shrinkage stress, marginal adaptation, and dentinal tubule fluid movement. To quantify the subclinical inflammatory response of the pulp, Gingival Crevicular Fluid (GCF) samples are collected from the gingival sulcus of the restored teeth at baseline and specific post-operative intervals (immediately and after one week ) to analyze changes in inflammatory mediators or biomarkers. Simultaneously, the patient's subjective experience of post-operative pain and thermal sensitivity is recorded using the Visual Analog Scale (VAS), where participants mark their level of discomfort on a 10-cm line to provide measurable data on clinical symptoms. By correlating these objective biochemical markers from the GCF with the subjective VAS scores and clinical sensibility testing, the study aims to identify the most effective packing protocol for minimizing C-factor-related stress and protecting the dentin-pulp complex from inflammatory responses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders.
  • Systemically healthy patients.
  • Good oral hygiene.
  • Available for follow-up appointments.
  • Asymptomatic permanent molars with deep occlusal caries ICDAS 5 or 6 carious lesions and healthy periodontium, in normal occlusion with no previous restorations related to the teeth and vital with a positive response to cold testing.

Exclusion criteria

  • Vulnerable populations.
  • Tobacco users.
  • Medically compromised patients, such as those with diabetes or medications affecting salivary flow were excluded.
  • Teeth with prior endodontic treatment, periodontal pockets over 3 mm, or any dental/periodontal therapy within the past 12 months.

Treatment and study plan

Sonic Fill bulk fill resin composite

Drug

The SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece. The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity

SDR flowable bulk fill resin composite

Procedure

SDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured. The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured.

Primary outcomes

  1. Pulpal inflammatory responses.

    Time frame: From enrollment to the end of treatment at one year.

    Immuno-histological analysis of the crevicular fluid to evalute pulpal inflammatory response by quantifying the volume of the pro-inflammatory cytokine TNF-α in GCF that reflect pulpal inflmmation in response to different resin composite packing techniques.

Secondary outcomes

  1. Post-operative pain.

    Time frame: From enrollment to the end of treatment at one year.

    This evaluation is conducted using the Visual Analog Scale (VAS), a validated 10-cm horizontal line where "0" represents "no pain" and "10" represents "the worst imaginable pain." Participants are instructed to record their subjective perception of discomfort at specific post-operative intervals (before treatment and one week following restorative procedures ). To ensure a comprehensive assessment, pain is categorized into spontaneous pain and provoked pain (sensitivity to thermal stimuli or masticatory pressure). This subjective data is then correlated with the biochemical findings from the Gingival Crevicular Fluid (GCF) samples.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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