Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite

NCT ID: NCT04152460

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-06-01

Brief Summary

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.

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 .

Conditions

Clinical Significance of Thermo-Viscous Composite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thermo-Viscous preheated bulk fill resin composite

Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)

Group Type: ACTIVE_COMPARATOR

Viscalor Bulk (VOCO,Cuxhaven)

Intervention Type: DEVICE

Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)

Conventional Bulk Fill resin Composite

GrandioSo X-tra (Voco,Cuxhaven

Group Type: PLACEBO_COMPARATOR

Grandioso x-tra

Intervention Type: OTHER

Nanohybrid Bulk Resin Composite

Interventions

Viscalor Bulk (VOCO,Cuxhaven)

Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)

Intervention Type: DEVICE

Grandioso x-tra

Nanohybrid Bulk Resin Composite

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Atef Ahmed Ibrahim

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olfat Hasanen

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Yasmin

Cairo, Mokattam, Egypt

Countries

Egypt

Other Identifiers

PHD-CU-2019-10-29

Identifier Type: -

Identifier Source: org_study_id