Clinical Evaluation of Self-Adhesive Bulk-Fil Hybrid Composite in Primary Molars

Clinical Evaluation of Self-Adhesive Bulk-Fil Hybrid Composite Restoration in Primary Molars

This study will evaluate the clinical performance of self-adhesive bulk-fill composite resin in the restoration of occlusal and occluso-proximal lesions in primary molars with hypothesis that there is no difference in the clinical performance of self-adhesive bulk-fill composite and traditional bulk-fill composite with adhesive over one year observation period

Study Overview

• Status: Active, not recruiting
• Conditions: Proximal Caries; Occlual Caries
• Intervention / Treatment: Other: self-adhesive bulk-fill resin composite

Detailed Description

Protocol of clinical procedure:After psychological management and preparation of the child, local anesthesia was administered in order to prevent pain upon cavity preparation and maintain the child's cooperation. Involved teeth were isolated using a rubber dam (DuraDam, Klang, Selangor D.E.,Malaysia). All cavities were cleaned and prepared using a high speed carbide bur (#330, MANI Inc, Tokyo, Japan) under a constant copious water-cooling system using a high-speed contra-angled hand piece (Dentsply Sirona, York, PA, USA). All occlusal pits and fissures were included in the cavity design to standardize the preparations. A small sectional contoured metal matrix (TOR VM, Russia) was placed interproximally and fixed with a wedge.

At this point, the operator defined the restorative material to be used by opening the allocation envelope.The cavities were restored in each subgroup with restorative material according to the manufacture instructions as follow:

In subgroup IA and IIA(cotrol groups), a 37% phosphoric acid etchant (Scotchbond Universal Etchant, 3M, ESP) was applied for 15 seconds on the dentine and 30 seconds on the enamel ,followed by washing for 40 seconds with water and gently air dried. The adhesive system (Scotchbond Universal Adhesive, 3M, ESPE, St. Paul, MN, USA) was applied actively to the entire surface using a disposable bond brush, for 20 seconds. The adhesive was dispersed into a thin layer with a gentle stream of air for 5 seconds, followed by light curing for 10 seconds using an LED light-curing unit (BluePhase N, Ivoclar Vivadent AG) with an intensity of 1200 mW/cm². Cavities were filled with FiltekTM Bulk Fill (St. Paul, MN, USA), in one increment and light cured for 20 seconds on each surface of the tooth with the same curing unit.

In subgroup IB and IIB (study groups), The cavities were cleaned using an air-water spray, leaving a moist cavity surface. Surefil one activated capsules (Dentsply Sirona, Konstanz, Germany) were mixed for 10 seconds using a capsule mixer (4200-5000 rpm) following the manufacturer's instructions. The restorative material was promptly dispensed into the prepared cavity using a capsule extruder. The dispensing process began at the cavity's deepest area, with the tip kept close to the bottom. The tip was gradually withdrawn as the cavity was filled in bulk and contoured with a hand instrument.(Following this, the restoration was cured for 20 seconds on each surface of the tooth with the same curing unit.

After that ,the occlusion was checked using articulating paper (Bausch, Nashua, NH, USA). The restorations were finished using a yellow-coded finishing flame stone (MANI Inc., Tokyo, Japan).Final polishing was performed using polishing disks (Soflex, 3M ESPE, MN, USA) while keeping the restoration moist with water spray.

Clinical evaluation: The restorations were evaluated clinically and radiographically according to Modified United States Public Health Organization (USHPS) criteria measuring marginal adaption, surface roughness, anatomic form, postoperative sensitivity, recurrent caries, retention, color match and proximal contact. These items were ranked according to the scores: Alpha -ideal clinical situation; Bravo-clinically acceptable; Charlie-clinically unacceptable situation. The evaluation was done post restoration(baseline) and at follow-up periods of 3, 6, and 12 months

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Sara Mahmoud Abd El-Razzak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Children with bilateral simple occlusal or occluso-proximal caries in the lower second primary molars.

  • Generally healthy children with no systemic disease.
  • Cooperative children with a behavior rating of 3 or 4 according to the Frankl Behavior Rating Scale.

Exclusion Criteria:

• Pulp exposure or indication for endodontic treatment or extraction.
• Teeth with symptoms such as spontaneous pain, swelling, infection, fistulae, abscesses or tenderness on percussion.
• Parents who weren't available for periodic follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3M bulk-fill composite resin class I; class I bulk-fill composite	Other: self-adhesive bulk-fill resin composite; surefil one self-adhesive bulk-fill composite
Active Comparator: 3M bulk-fill compsite resin class II; class I bulk-fill	Other: self-adhesive bulk-fill resin composite; surefil one self-adhesive bulk-fill composite
Experimental: surefil one class I; class I surefil one	Other: self-adhesive bulk-fill resin composite; surefil one self-adhesive bulk-fill composite
Experimental: surefil one class II; class II surefil one	Other: self-adhesive bulk-fill resin composite; surefil one self-adhesive bulk-fill composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified United States Public Health Organization (USPHS) criteria for evaluation	one year follow up

Collaborators and Investigators

• Sponsor: Mansoura University

Publications and helpful links

General Publications

• Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 19, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: primary molars; Bulk-fill composite; restorative treatment; self-adhesive bulk-fill composite; occlusal lesions; occluso-proximal lesions
• Other Study ID Numbers: A06020822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No