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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Posterior Complex Carious Proximal Cavities
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Alghaffar khafagi, master; Phone Number: 01016997764; Email: ahmed.khafagi@dentistry.cu.edu.eg
• Study Contact Backup: Name: fatheya el shinawy, master; Phone Number: 01007830829

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University,
    • Contact: Faculty of Dentistry, Cairo University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.; 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.
Experimental: 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.	Other: 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.; 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.; 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.
Experimental: 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	Other: 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.; 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.; 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.
Active Comparator: 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.	Other: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal Contact quality	50 micro sectional matrix band (Saddle matrix, TORVM, Moscow, Russia) FDI criteria (Hickel et al., 2010)	one year follow up

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Alghaffar khafagi, master, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 26, 2022
• Primary Completion (Anticipated): November 6, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Vasodilator Agents; Protective Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: 14422018454217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No