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

NCT06724939 | Active Not Recruiting

• 1 other identifier: A06020822
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Occlual Caries; Proximal Caries

Keywords

Bulk-fill composite; self-adhesive bulk-fill composite; primary molars; restorative treatment; occlusal lesions; occluso-proximal lesions

Outcome Measures

Primary Outcomes (1)

• Modified United States Public Health Organization (USPHS) criteria for evaluation

  one year follow up

Study Arms (4)

3M bulk-fill composite resin class I

ACTIVE COMPARATOR

class I bulk-fill composite

Other: self-adhesive bulk-fill resin composite

3M bulk-fill compsite resin class II

ACTIVE COMPARATOR

class I bulk-fill

Other: self-adhesive bulk-fill resin composite

surefil one class I

EXPERIMENTAL

class I surefil one

Other: self-adhesive bulk-fill resin composite

surefil one class II

EXPERIMENTAL

class II surefil one

Other: self-adhesive bulk-fill resin composite

Interventions

self-adhesive bulk-fill resin composite OTHER

surefil one self-adhesive bulk-fill composite

3M bulk-fill composite resin class I; 3M bulk-fill compsite resin class II; surefil one class I; surefil one class II

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Sara Mahmoud Abd El-Razzak

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35273277 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operator was not blinded to the allocation of the material because of the distinct application approach for the restorative materials, which prohibited doing so. However, the participants(children) ,their caregivers, and the statistician were blinded to the restorative material used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The children will be randomly divided into 2 main groups according to the type of carious lesion:Group I occlusal lesions.Group II occluso-proximal lesions. Then the children will be randomly sub grouped according to the type of restorative materials that will be used:Group IA and group IIA with filtek 3M bulk-fill resin composite .Group IB and IIB with surefil one restorative materials

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: September 12, 2022
• Primary Completion: December 30, 2024
• Study Completion: January 19, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)