The Proximal Contact Tightness and Location in Class II Composite Restorations
- Conditions
- Tooth Decay
- Interventions
- Other: Precontoured sectional matrix EZ COATOther: PerForm™Other: Contact Pro™Other: AdDent Trimax™
- Registration Number
- NCT05749640
- Lead Sponsor
- karim mohamed
- Brief Summary
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- Presence of the antagonist and the adjacent tooth making contact.
- The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
- Size of the isthmus with no more than 2/3 of the intercuspal distance
- Good oral health and absence of periodontal disease
- Patients who are not suffering from severe systemic diseases or allergies
- Medically compromised patients
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Palodent® plus sectional matrix system "Control group" Precontoured sectional matrix EZ COAT - PerForm™ "Experimental" PerForm™ - Contact Pro™ "Experimental" Contact Pro™ - Trimax™ "Experimental" AdDent Trimax™ -
- Primary Outcome Measures
Name Time Method Change in proximal contact tightness baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
- Secondary Outcome Measures
Name Time Method Change in proximal contact location baseline and immediately postoperative calibration will be carried out by a radiologist, who evaluates the teeth carefully scrolling down through the images from the floor of the pulp chamber in all three orthogonal reconstructions (axial, coronal, and sagittal). To ensure image standardization, all cone-beam computed tomography (CBCT) images will be chosen from a single machine with a standard field of view, voxel size, exposure time and the thickness of the slice.
CBCT images will be analyzed with the built-in digital imaging software. The measurement tool will be used to determine the total length of the crown of the restored teeth, measured from the tip of the mesiobuccal cusp to the cementoenamel junction. Based on this length, the crown portion will be divided into three levels: coronal, middle and apical thirds.
Trial Locations
- Locations (1)
Karim Mohamed Wahba Abbass
🇪🇬Alexandria, Egypt