Evaluation of the Proximal Contact Quality in Posterior Complex Carious Cavities Restored With Bulk Fill Ormocer and Resin Composite Using a Precontoured Circumferential Matrix System Versus Pre Contoured Sectional Matrix System

NCT ID: NCT05625243

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-26

Study Completion Date

2023-12-31

Brief Summary

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The use of ormocers with precontoured circumferential matrix system allow predictable restoration of complex proximal posterior cavities with less time and fewer tools required to produce optimum proximal contact size, location and magnitude and restoration durability with higher wear resistance.

Detailed Description

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After profound local anesthesia, conservative cavity preparations will be performed with high-speed burs (no.:330, Meisinger, Germany) under constant refrigeration. Intermittent rotary instrument contact with tooth limited to the removal of compromised enamel. The cavity outline is restricted to the removal of carious tissue with spherical carbide burs at low speed. In the removal of defective restorations, the friable enamel and remnant carious tissue will be removed in the same way. All teeth will be restored using a rubber dam. The universal bonding agent (Voco, Cuxhaven, Germany) will be applied with previous selective enamel etching with 37% phosphoric acid for 30 seconds. These materials will be inserted following the manufacturer's instructions.

After cavity preparation, each participant will choose a random number from an opaque sealed envelope, then patient will select from random numbers prepared by Y.H. to randomly assign interventions to the participant oral cavity.

All restorations will be prepared, restored, finished and polished by one operator.

Conditions

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Posterior Complex Carious Proximal Cavities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bulk-fill ormocer with Precontoured circumferential matrix system

A suitable size precontoured circumferential matrix band will be selected and placed. Teeth separation will be acquired with a suitable size wedge and a separation ring . Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions.

Group Type EXPERIMENTAL

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)

Intervention Type OTHER

A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill ormocer with Precontoured Saddle matrix system

Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges and a separation ring Then the bulk-fill ormocer will be applied and light cured according to the manufacturer instructions.

Group Type EXPERIMENTAL

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)

Intervention Type OTHER

A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply )

.Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied

Group Type EXPERIMENTAL

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)

Intervention Type OTHER

A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill resin composite with Precontoured sectional matrix systym

Teeth separation will be acquired with a wooden wedge and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk fill resin composite will be applied and light cured according to the manufacturer instructions.

Group Type ACTIVE_COMPARATOR

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)

Intervention Type OTHER

A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

Intervention Type OTHER

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Interventions

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Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Intervention Type OTHER

Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)

A suitable size precontoured sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (fixing wooden wedges, TORVM, Moscow, Russia) and a separation ring (Delta ring, TORVM, Moscow, Russia). Then the bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Intervention Type OTHER

Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

A suitable size precontoured circumferential matrix band (Palodent 360, Dentsply Caulk, Millford DE, USA) will be selected and placed. Teeth separation will be acquired with a suitable size wedge (Palodent V3, Dentsply Caulk, Millford DE, USA) and a separation ring (Palodent V3 universal ring, Dentsply Caulk, Millford DE, USA). Then the bulk fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) will be applied and light cured according to the manufacturer instructions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Posterior complex proximal carious lesions Vital upper or lower posterior teeth with no signs of irreversible pulpitis. Presence of adjacent and opposing teeth with normal occlusion

Exclusion Criteria

* Proximal carious cavities in the mesial surface of first premolars. Periapical pathology or signs of pulpal pathology. Possible prosthodontic restoration of teeth. Heavy occlusion and occlusal contacts or history of bruxism. Pulpitis, non-vital or endodontically treated teeth. Sever periodontal affection
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abd Alghaffar Khafagi

Evaluation of the proximal contact quality in posterior complex carious cavities restored with bulk fill ormocer and resin composite using a precontoured circumferential matrix system versus precontoured sectional matrix system

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Alghaffar khafagi, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Dentistry, Cairo University,

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Alghaffar khafagi, master

Role: CONTACT

01016997764

fatheya el shinawy, master

Role: CONTACT

01007830829

Facility Contacts

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Faculty of Dentistry, Cairo University,

Role: primary

Other Identifiers

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14422018454217

Identifier Type: -

Identifier Source: org_study_id

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