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

Not Applicable

Not yet recruiting

• Conditions: Posterior Complex Carious Proximal Cavities
• Interventions: Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA); Other: Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia); Other: Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)

• Registration Number: NCT05625243
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Study Start: 2022-11-26
• Primary Completion: 2023-11-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply )	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	.Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied
X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply )	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)	.Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied
Bulk-fill ormocer with Precontoured circumferential matrix system	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 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.
Bulk-fill ormocer with Precontoured Saddle matrix system	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	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.
Bulk-fill ormocer with Precontoured circumferential matrix system	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)	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.
X-tra fill, Voco) with Precontoured circumferential matrix (Palodent 360, Dentsply )	Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	.Bulk-fill resin composite (X-tra fill, Voco) with Precontoured circumferential matrix system (Palodent 360) will be applied
Bulk-fill ormocer with Precontoured Saddle matrix system	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)	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.
Bulk-fill ormocer with Precontoured Saddle matrix system	Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	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.
Bulk-fill resin composite with Precontoured sectional matrix systym	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	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.
Bulk-fill resin composite with Precontoured sectional matrix systym	Bulk-fill resin composite (X-tra fill, Voco, Cuxhaven, Germany) with Precontoured circumferential matrix system (Palodent 360, Dentsply Caulk, Millford DE, USA)	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.
Bulk-fill ormocer with Precontoured circumferential matrix system	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 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.
Bulk-fill resin composite with Precontoured sectional matrix systym	Bulk-fill ormocer (Admira fusion x-tra, Voco, Cuxhaven, Germany) with Precontoured sectional matrix systym (Saddle matrix, TORVM, Moscow, Russia)	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.

Primary Outcome Measures

Name	Time	Method
Proximal Contact quality	one year follow up	50 micro sectional matrix band (Saddle matrix, TORVM, Moscow, Russia); FDI criteria (Hickel et al., 2010)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University,; 🇪🇬 Cairo, Egypt