Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite

Clinical Significance of Thermo-Viscous Composite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04152460
• Other study ID #: PHD-CU-2019-10-29
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Significance of Thermo-Viscous Composite

Intervention

Device:
• Viscalor Bulk (VOCO,Cuxhaven)
Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)

Other:
• Grandioso x-tra
Nanohybrid Bulk Resin Composite

Locations

Country	Name	City	State
Egypt	Yasmin	Cairo	Mokattam

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Integrity	Modified US Public Health Service Criteria (USPHS)	1 year
Secondary	Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )	Modified US Public Health Service Criteria (USPHS)	1 year