Evaluation of Clinical Performance of Bulk Fill Resin Composite Restorations Using Snow Plow Versus Oscillating Packing Technique

NCT07033650 | Completed

• 1 other identifier: 906/2024
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, double-blinded clinical trial (the patient and the examiners are blind to the group assignment). Eligible patients will be examined clinically and radiographically using bite-wing radiography, and recruited according to the previously mentioned inclusion and exclusion criteria. All participants will sign written informed consents after being completely aware of the aim, settings, procedures, benefits and potential side effects of the study. Each tooth will be assigned by a number; R1 (Bulk fill RC), R2 (Snow plow tech) and R3 (Oscillating tech). Restoration numbers will be concealed in an opaque sealed envelope that will be held by a facilitator who will not involve in any of the phases of the clinical trial. Every patient will choose an envelope for each tooth. Patients and examiners will be blinded to the material assignment; the operator also will be blinded for the type of restoration during tooth preparation and will be informed only at the time of restoration placement. Each case will be evaluated according to FDI criteria, based on both functional (Fracture of material and retention, Marginal adaptation, Occlusal contour and wear, Proximal contact point and food impaction, and Radiographic examination) and biological (Postoperative sensitivity, Recurrence of caries and Tooth integrity) properties. Bitewing radiographs and intra-oral photographs will be also used for assessment of all restorations. Assessment of postoperative sensitivity and tooth vitality will be carried out on the patient by application of a cold stimulus (e.g. a blast of cold air). Postoperative sensitivity will be recorded at the time of restoration placement, and throughout all follow-up appointments, and include type of pain, discomfort and duration, and/or on stimulus at clinical assessment and should always be compared with the response of adjacent vital teeth. Intensity will be assessed also with a visual analogue scale (VAS) which is a commonly used tool for measuring pain. On a scale of 1 to 5, restorations will be rated as follows; score 1: clinically excellent/very good, 2: clinically good, 3: clinically satisfactory, 4: clinically unsatisfactory but repairable and 5: clinically poor/irrepairable and in need of replacement. So the scores 1, 2 and 3 considered clinically successful while scores 4 and 5 considered clinically not successful.

Conditions

Caries Class Ii

Outcome Measures

Primary Outcomes (3)

• Adaptation of restorations

  magnifying loupes (4.5x; Carl Zeiss GmbH, Jena, Germany) will be recommended for evaluation. In addition, a set of blunt explorers, straight and double angled for proximal sites, with different blunt tips of 50, 150, and 250 μm will be utilized to assess the gap size between tooth and restoration. The explorer was drawn across the restoration's surface toward the tooth to detect marginal ditching, irregularities or fracture. If the explorer catches, it means the restoration's edges haven't adapted closely to the tooth structure

  at baseline (immediately after restoration), after 3 months, 6 months, and 12 months

• Radiographic examination of the restorations

  A scale of 5 pints 1-5 , where 1 consider no pathology with harmonious transition between tooth and restoration 2 mean small visible but acceptable excess or gap 3 means gaps or excess still within acceptable range 4 means gaps or marked excess material in inter radicular 5 means gaps or secondary caries or apical pathology or fracture

  at baseline (immediately after restoration), after 3 months, 6 months, and 12 months

• postoperative sensitivity and tooth vitality using VAS

  Intensity will be assessed also with a visual analogue scale (VAS) which is a tool widely used to measure pain. The Visual Analogue Scale (VAS) consists of a 100 mm horizontal line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Score less than 5 mm will be labeled as no pain, scores from 5 to 44 mm will be labeled as mild pain, scores from 45 to 74 mm will be labeled as moderate pain, and scores 75 mm and greater will be labeled as sever pain.

  at baseline (immediately after restoration), after 3 months, 6 months, and 12 months

Study Arms (3)

Control

ACTIVE COMPARATOR

teeth will be restored with the packable Bulk-fill composite (X-tra Fil) with a single increment of 4 mm starting with the proximal boxes and cured for 10 s

Other: Bulk-fill composite (X-tra Fil)

Snowplow" technique

EXPERIMENTAL

teeth will be restored using Snowplow technique where a 1 mm layer of flowable Bulk-fill composite (X-tra Base) will be deposited at the gingival margin of the prepared teeth and kept uncured. Then pushing a heavily filled packable nanohybrid resin composite (X-tra Fil) into the uncured flowable composite. The combined layer of flowable and restorative composites will be then cured using LED curing unit for 10 s

Other: Bulk-fill composite (X-tra Fil); Other: flowable Bulk-fill composite (X-tra Base)

Oscillating technique

EXPERIMENTAL

teeth will be restored using oscillating technique where the packable Bulk-fill composite material will be placed in bulk to fill the prepared cavity using a plastic filling instrument then the compothixo oscillating packing instrument will be used The oscillation energy (140 Hz) will be applied for 30 s, during which the composite will be adapted to all the cavity walls, and then light cured for 10 s.

Other: Bulk-fill composite (X-tra Fil); Device: compothixo oscillating packing

Interventions

Bulk-fill composite (X-tra Fil) OTHER

Bulk fill resin composite

Control; Oscillating technique; Snowplow" technique

flowable Bulk-fill composite (X-tra Base) OTHER

flowable resin composite

Snowplow" technique

compothixo oscillating packing DEVICE

oscillating packing device

Oscillating technique

Eligibility Criteria

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

You may qualify if:

• Each patient should have at least three occluso-proximal carious lesions in the posterior molars in three different quadrants (two upper and one lower)
• Only co-operative patients approving to participate in the trial.

You may not qualify if:

• Patients with disabilities or severe medically compromised.
• Patients with severe bruxism, clenching or temporomandibular joint disorders.
• Patients with allergy to any components of the materials.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Conservative Dentistry, Faculty of Dentistry, Suez Canal University

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 24, 2025
• Study Start: January 25, 2024
• Primary Completion: February 2, 2025
• Study Completion: March 21, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)