Clinical trial NCT06532916: Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
Official title: Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resin Composite Restorations
Esthetic Restorations
Keywords: Resin composites
Injectable resins
Preheated resins
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2024-08-01
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of the study will be a double blinded (Evaluator and Patient) split-mouth randomized clinical study with two study groups.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique.

Detailed description: The design of study will be a modified split-mouth randomized clinical trial with two study groups. 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations. A total of 142 restorations will be assigned into two groups. In the first group, 71 anterior teeth will be restored with flowable composite veneer restorations, and the second group 71 anterior teeth will be restored with heated composite veneer restorations. Both treatment groups will be done using the injectable resin technique. The following parameters will be evaluated at baseline, 6 months and 12 months of clinical service. Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer. Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner. Clinical performance will be evaluated using the USPHS criteria. It is expected that the color stability, wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Asymptomatic sound anterior teeth, or localized Class III/IV/V cavity or restoration
* Patients with irregular tooth anatomies, misalignments, spacing, mild staining, cervical wear that are indicated for direct composite veneers
* Restorations in functional occlusions with an opposing natural tooth.
* Two proximal contacts area with neighboring teeth

Exclusion Criteria:

* Patients with contra-indications for regular dental treatment based on their medical history.
* Patients at a high risk of caries.
* Patients with poor oral hygiene.
* Teeth with compromised periodontal status.
* Evidence of active parafunctional habits or excessive tooth wear.
* Severe discoloration
* Heavy smokers
* Patients with special aesthetic requirements that could not be solved by direct composite veneers.

Primary outcomes:
measure: The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts.
timeFrame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
measure: The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts.
timeFrame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Ghada A Maghaireh
role: PRINCIPAL_INVESTIGATOR
References: