The Proximal Contact Tightness and Location in Class II Composite Restorations

Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments

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.

Study Overview

• Status: Completed
• Conditions: Tooth Decay
• Intervention / Treatment: Other: Precontoured sectional matrix EZ COAT; Other: PerForm™; Other: AdDent Trimax™; Other: Contact Pro™

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 00000
    • Karim Mohamed Wahba Abbass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palodent® plus sectional matrix system "Control group"	Other: Precontoured sectional matrix EZ COAT; All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)
Experimental: PerForm™ "Experimental"	Other: PerForm™; Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Experimental: Trimax™ "Experimental"	Other: AdDent Trimax™; Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Experimental: Contact Pro™ "Experimental"	Other: Contact Pro™; Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proximal contact tightness	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	baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proximal contact location	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.	baseline and immediately postoperative

Collaborators and Investigators

• Sponsor: karim mohamed

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: AlexandriaU 0425-04/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No