Clinical trial NCT04152460: Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite
Official title: Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Significance of Thermo-Viscous Composite
Keywords: Bulk-fill resin Composite
Thermo-Viscous resin Composite
Proximal Compound Cavities
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Marginal Integrity
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yasmin
state: Mokattam
Study officials:
affiliation: Cairo University
name: Olfat Hasanen
role: PRINCIPAL_INVESTIGATOR
References: