NCT07033650: RCT

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

Completed NA Last updated 24 June 2025

What this trial tests

NA trial testing Bulk-fill composite (X-tra Fil) in Caries Class Ii in 87 participants. Completed in 21 March 2025.

Timeline

25 January 2024

Primary endpoint
2 February 2025

21 March 2025

Quick facts

Lead sponsor	Suez Canal University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	87
Start date	25 January 2024
Primary completion	2 February 2025
Estimated completion	21 March 2025
Sites	1 location across Egypt

Drugs / interventions tested

• Bulk-fill composite (X-tra Fil)
• flowable Bulk-fill composite (X-tra Base)
• compothixo oscillating packing

Conditions studied

• Caries Class Ii — all drugs for Caries Class Ii →

Sponsor

Suez Canal University

Who can join

Adults 21 to 50, any sex, with Caries Class Ii. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.