A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.

NCT06032689 | Completed

• 1 other identifier: M 11120520
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.

Conditions

Dental Caries Class II

Outcome Measures

Primary Outcomes (1)

• clinical performance

  FDI criteria

  two years

Study Arms (4)

Xtra-fill

ACTIVE COMPARATOR

Bulk-fill high-viscosity methacrylate-based resin composites.

Combination Product: Xtra-fill

X-base

ACTIVE COMPARATOR

Bulk-fill low-viscosity methacrylate-based resin composites.

Combination Product: x-base

Admira fusion x-tra

ACTIVE COMPARATOR

Bulk-fill high-viscosity ormocer-based resin composites.

Combination Product: Admira fusion x-tra

Admira fusion x-base

ACTIVE COMPARATOR

Bulk-fill low-viscosity ormocer-based resin composites.

Combination Product: Admira fusion x-base

Interventions

Xtra-fill COMBINATION_PRODUCT

the material was placed in bulk.

Xtra-fill

x-base COMBINATION_PRODUCT

The x-base liner was placed and then veneered with Xtra-fill.

X-base

Admira fusion x-tra COMBINATION_PRODUCT

bulk placement of the restoration Admira fusion -xtra.

Admira fusion x-tra

Admira fusion x-base COMBINATION_PRODUCT

Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.

Admira fusion x-base

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
• Patients ranging in age from 18 to 30 years.
• patients with normal occlusion.

You may not qualify if:

• Patients having severe chronic periodontitis.
• Patients with orthodontic appliances.
• Abnormal occlusion, parafunctional habits.
• Teeth with irreversible pulpitis or non-vital.
• Fractured or cracked teeth.
• Previously restored teeth.
• Cavities with isthmus larger than intercuspal distance.
• Teeth with deep sub-gingival cavity margins.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura U

Al Mansurah, Mansoura, 35511, Egypt

Location

Study Officials

• Sa Mahmoud, professor

  Operative Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: September 13, 2023
• Study Start: January 15, 2020
• Primary Completion: April 27, 2022
• Study Completion: June 17, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

EG (1)