Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

4 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Egypten
      • Giza, Egypten, 3235142
        • Ain Shams University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
Läkemedel: 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
Experimentell: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pulpal inflammatory responses.
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Post-operative pain.
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

October 6 University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2025

Primärt slutförande (Faktisk)

1 januari 2026

Avslutad studie (Faktisk)

1 januari 2026

Studieregistreringsdatum

Först inskickad

4 juli 2026

Först inskickad som uppfyllde QC-kriterierna

4 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FDASU-Rec IM012562

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera