The Proximal Contact Tightness and Location in Class II Composite Restorations

karim mohamed

Status: Completed

Conditions: Tooth Decay

Treatments: Other: Contact Pro™; Other: AdDent Trimax™; Other: Precontoured sectional matrix EZ COAT; Other: PerForm™

Study type: Interventional

Funder types: Other

Identifiers

NCT05749640

AlexandriaU 0425-04/2022

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 4 patient groups

Palodent® plus sectional matrix system "Control group"

Active Comparator group

Treatment:

Other: Precontoured sectional matrix EZ COAT

PerForm™ "Experimental"

Experimental group

Treatment:

Other: PerForm™

Trimax™ "Experimental"

Experimental group

Treatment:

Other: AdDent Trimax™

Contact Pro™ "Experimental"

Experimental group

Treatment:

Other: Contact Pro™