Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)
4. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
30
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Giza, Egypt, 3235142
- Ain Shams University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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.
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Experimentální: 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. |
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
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Experimentální: 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. |
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pulpal inflammatory responses.
Časové okno: From enrollment to the end of treatment at one year.
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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.
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From enrollment to the end of treatment at one year.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Post-operative pain.
Časové okno: From enrollment to the end of treatment at one year.
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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.
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From enrollment to the end of treatment at one year.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. února 2025
Primární dokončení (Aktuální)
1. ledna 2026
Dokončení studie (Aktuální)
1. ledna 2026
Termíny zápisu do studia
První předloženo
4. července 2026
První předloženo, které splnilo kritéria kontroly kvality
4. července 2026
První zveřejněno (Aktuální)
10. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FDASU-Rec IM012562
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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