Evaluation of Organically Modified Ceramic Resin Composite Versus Bulkfill Resin in Proximal Posterior Cavities

NCT04677023 | Unknown DMC

• 1 other identifier: 88960
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients with compound posterior proximal cavities, will the use of organically modified ceramic resin composite restorative material have similar clinical performance to conventional bulk fill resin composite, evaluation of restorations will be done at baseline,six and twelve months using World Dental Federation FDI criteria.

Conditions

Proximal Caries

Outcome Measures

Primary Outcomes (1)

• Fracture

  Fracture of material visually inspected and evaluated using FDI probe and then classified accordingly 1. clinically excellent/very good: No fractures /cracks. 2. Clinically good: Small hairline crack. 3. Clinically sufficient /satisfactory(minor shortcomings, no unacceptable effects but not adjustable w/or damage to the tooth):Two or more or larger hairline cracks and/or material chipfracture no affecting the marginal integrity or approximal contact. 4. Clinically unsatisfactory /(but reparable):Material chip fractures which damage marginal quality or Bulk fractures with partial loss(less than half of the restoration). ditching or marginal fractures. 5. Clinically poor (replacement necessary): (Partial or complete) loss of restoration or multiple fractures.

  24 months

Secondary Outcomes (1)

• color match

  24 months

Other Outcomes (1)

• secondary caries

  24 months

Study Arms (2)

Admira fusion X--tra® bulk

OTHER

The special ORMOCER® compound molecules in Admira Fusion x-tra reduce the volume shrinkage to an extremely low level (1.25 % by volume) in conjunction with very low shrinkage stress (3.87 MPa). Admira Fusion x-tra is the bulk fill version of Admira Fusion. This means that this restorative material can be applied in layers of up to 4 mm and then reliably cured. This makes placing posterior restorations particularly quick and economical. The universal shade U further simplifies handling, as it provides aesthetic results by adapting, chameleon-like, to the surrounding dental substance

Other: Admira fusion X--tra® bulk

GrandioSO x-tra® bulk

OTHER

a nano-hybrid composite which is in a class of its own. It is distinguished by outstanding handling and excellent physical properties, modelled on the natural tooth.its the packable bulk fill material for the highest standards in durability and aesthetics.GrandioSO x-tra has outstanding surface hardness, at 223 MHV, which is closer to natural tooth enamel, compared with other bulk fill composites. Because of this, GrandioSO x-tra ensures restorations which are abrasionresistant and dimensionally stable over the long term. In addition to the surface hardness, reliable curing is very important when larger increments are used. Here as well, GrandioSO x-tra achieves an outstanding result and, at the 219 MHV measured at a depth of 4 mm, it even significantly exceeds the values measured for other bulk fill composites at the surface.

Other: GrandioSO x-tra® bulk

Interventions

GrandioSO x-tra® bulk OTHER

The prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.

GrandioSO x-tra® bulk

Admira fusion X--tra® bulk OTHER

he prepared cavities will be restored with Admira fusion X-tra®️ bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.

Admira fusion X--tra® bulk

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging ≥18 years.
• Patients with a high level of oral hygiene.
• Patients having at least 1or 2 posterior teeth in occlusion.
• Patients with good likelihood of recall availability.
• Permanent premolars or molars.
• Moderate to deep compound class II cavities.
• Primary carious lesions.
• Vital with positive reaction to cold thermal stimulus.
• Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.

You may not qualify if:

• Participants with general/systemic illness.
• Pregnant or lactating females.
• Concomitant participation in another research study.
• Inability to comply with study procedures.
• Heavy bruxism habits.
• Last experience with allergic reactions against any components of the used materials.
• Patients receiving orthodontic treatment.
• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth.
• Secondary carious lesions.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investegator

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: expecting to have all the data by October 2022