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

NCT07694661 | Completed Phase 4 DMC

• 1 other identifier: FDASU-Rec IM012562
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Carious Lesion

Keywords

SonicFill , SDR , elastic liner, pulp inflammation , post-operative pain, GCF , TNF-α.

Outcome Measures

Primary Outcomes (1)

• Pulpal inflammatory responses.

  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.

Secondary Outcomes (1)

• Post-operative pain.

  From enrollment to the end of treatment at one year.

Study Arms (3)

Flowable liner and packable composite

NO INTERVENTION

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.

Sonic Fill bulk fill resin composite

EXPERIMENTAL

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.

Drug: Sonic Fill bulk fill resin composite

SDR flowable bulk fill resin composite

EXPERIMENTAL

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

Interventions

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

Sonic Fill bulk fill resin composite

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.

SDR flowable bulk fill resin composite

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Ain shams university

Giza, 3235142, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant.

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

EG (1)