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

4 juli 2026 bijgewerkt door: Esraa Mohamed Zaki, October 6 University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
      • Giza, Egypte, 3235142
        • Ain Shams University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Flowable liner and packable composite
Following proper administration of local anesthesia , cavity preparation is completed according to the study's standardized dimensions. Isolation is achieved using a rubber dam to ensure a moisture-free operating field. Selective-etch is performed using 37% phosphoric acid, followed by thorough rinsing and gentle air-drying to leave the dentin moist. The bonding agent is applied according to the manufacturer's instructions, gently air-thinned to form a uniform layer, and light-cured for the specified duration. A low-viscosity flowable composite liner is applied to the pulpal floor generally not exceeding 1-2 mm in thickness. he remaining cavity depth is restored using a packable resin composite using an incremental layering technique to minimize polymerization shrinkage stress. Each increment is meticulously adapted to the cavity walls using a hand plugger, anatomically contoured, and light-cured individually from the occlusal surface.
Experimenteel: Sonic Fill bulk fill resin composite

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.
Geneesmiddel: Sonic Fill bulk fill resin composite
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
Experimenteel: SDR flowable bulk fill resin composite

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.
Procedure: SDR flowable bulk fill resin composite
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pulpal inflammatory responses.
Tijdsspanne: 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.
From enrollment to the end of treatment at one year.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Post-operative pain.
Tijdsspanne: 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.
From enrollment to the end of treatment at one year.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

October 6 University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2025

Primaire voltooiing (Werkelijk)

1 januari 2026

Studie voltooiing (Werkelijk)

1 januari 2026

Studieregistratiedata

Eerst ingediend

4 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FDASU-Rec IM012562

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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