Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite

Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial

A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.

Study Overview

• Status: Active, not recruiting
• Conditions: Clinical Significance of Thermo-Viscous Composite
• Intervention / Treatment: Device: Viscalor Bulk (VOCO,Cuxhaven); Other: Grandioso x-tra

Detailed Description

Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable .

Preheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage.

A new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency.

Preheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties .

Follow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mokattam
    • Cairo, Mokattam, Egypt, 11865
      • Yasmin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aging more than 18 years .
• Patients with a high level of oral hygiene.
• Patients having at least 12 posterior teeth in occlusion.
• Patients with good likelihood of recall availability.

Tooth Inclusion :

• Permanent premolars and molars.
• Moderate to deep compound class II cavities.
• well formed fully erupted .
• Vital with positive reaction to cold and hot stimulus.

Exclusion Criteria:

• Participants with general systematic illness.
• Pregnant or lactating females.
• Concomitant participation in another research study.
• Inability to comply with study procedures.
• Heavy Bruxism habits.
• Patients receiving Orthodontic treatment.
• last experience with allergic reactions against any component of used materials .

Tooth exclusion :

• Non vital teeth.
• Secondary carious lesions.
• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thermo-Viscous preheated bulk fill resin composite; Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)	Device: Viscalor Bulk (VOCO,Cuxhaven); Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)
Placebo Comparator: Conventional Bulk Fill resin Composite; GrandioSo X-tra (Voco,Cuxhaven	Other: Grandioso x-tra; Nanohybrid Bulk Resin Composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Integrity	Modified US Public Health Service Criteria (USPHS)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )	Modified US Public Health Service Criteria (USPHS)	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Olfat Hasanen, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Bulk-fill resin Composite; Thermo-Viscous resin Composite; Proximal Compound Cavities
• Other Study ID Numbers: PHD-CU-2019-10-29

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