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

Primary Purpose

Dental Caries Class II

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Xtra-fill
x-base
Admira fusion x-tra
Admira fusion x-base
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Class II

Eligibility Criteria

18 Years - 33 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: General exclusion criteria: Patients having severe chronic periodontitis. Patients with orthodontic appliances. Abnormal occlusion, parafunctional habits. Allergy to any of the materials used in the study. Specific teeth exclusion criteria 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.

Sites / Locations

  • Mansoura U

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Xtra-fill

X-base

Admira fusion x-tra

Admira fusion x-base

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

clinical performance
FDI criteria

Secondary Outcome Measures

Full Information

First Posted
August 2, 2023
Last Updated
September 9, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06032689
Brief Title
A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.
Official Title
Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
June 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study was designed following the Consolidated Standards of Reporting Trials (CONSORT) statement. approvement by the local ethics committee of Mansoura University code register was taken code M 11120520. The patients were selected as they searched for treatment in the Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura University. A group of 30 patients 21 Females and 9 males was chosen from among 92 participants after careful consideration of the inclusion and exclusion criteria. The sample size estimate was made based on the clinical success rate of posterior class II composite restorations observed in a prior study (97.5% at 24 months). The sample size needed per group was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%. A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after taking potential dropouts into account. To ensure adherence of the participants to the study, all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four attempts, including visits to the schools, were made to contact a volunteer before he/she was considered a "loss." both participants and examiners were blind to the interventions. An inter-examiner and intra-examiner agreement of at least 90% was requested before the beginning of the evaluation. Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World Dental Federation (FDI) criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xtra-fill
Arm Type
Active Comparator
Arm Description
Bulk-fill high-viscosity methacrylate-based resin composites.
Arm Title
X-base
Arm Type
Active Comparator
Arm Description
Bulk-fill low-viscosity methacrylate-based resin composites.
Arm Title
Admira fusion x-tra
Arm Type
Active Comparator
Arm Description
Bulk-fill high-viscosity ormocer-based resin composites.
Arm Title
Admira fusion x-base
Arm Type
Active Comparator
Arm Description
Bulk-fill low-viscosity ormocer-based resin composites.
Intervention Type
Combination Product
Intervention Name(s)
Xtra-fill
Intervention Description
the material was placed in bulk.
Intervention Type
Combination Product
Intervention Name(s)
x-base
Intervention Description
The x-base liner was placed and then veneered with Xtra-fill.
Intervention Type
Combination Product
Intervention Name(s)
Admira fusion x-tra
Intervention Description
bulk placement of the restoration Admira fusion -xtra.
Intervention Type
Combination Product
Intervention Name(s)
Admira fusion x-base
Intervention Description
Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.
Primary Outcome Measure Information:
Title
clinical performance
Description
FDI criteria
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: General exclusion criteria: Patients having severe chronic periodontitis. Patients with orthodontic appliances. Abnormal occlusion, parafunctional habits. Allergy to any of the materials used in the study. Specific teeth exclusion criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sa Mahmoud, professor
Organizational Affiliation
Operative Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura U
City
Mansoura.
State/Province
Mansoura
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

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

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