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Completed

NCT Number: NCT05749640

The Proximal Contact Tightness and Location in Class II Composite Restorations

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.

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Key information

Conditions

Tooth Decay Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karim Mohamed Wahba Abbass

Alexandria, 00000, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Precontoured sectional matrix EZ COAT

Other

All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)

PerForm™

Other

Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

AdDent Trimax™

Other

Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Contact Pro™

Other

Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)

Primary outcomes

  1. Change in proximal contact tightness

    Time frame: 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 outcomes

  1. Change in proximal contact location

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

karim mohamed

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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