Injectable Resin Composite Versus Dual-cured Resin Cement for Cementation of Indirect Onlay Restorations

NCT05954156 | Completed

• 1 other identifier: IRS_DCRC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Marginal integrity is considered the main essential part of indirect restorations and any discrepancy after cementation and poor marginal fit can lead to microleakage, marginal discoloration, dissolution of cement and secondary caries. The type of cement used plays an important role and can govern the amount of augmentation in discrepancy after cementation. Although resin cement is still the gold standard luting agent for the cementation of all indirect restoration, it lacks some properties that may be available in the restorative resin composite such as higher filler loading, higher mechanical properties and wear resistance. may have been the first to propose the use of restorative, flowable resin composite as a luting agent for ceramic inlays. These authors demonstrated that with respect to polymerization rate, there were no advantages of dual curing-resin compared to light curing only. In addition, the overall handling of the light-curing flowable restorative resin composite was judged to be easier than that of the dual cured material. The same conclusions were drawn by Kramer and franken Berger who added that less luting resin composite overhangs were found with the light polymerized composite-resin because the clinician has more time for excess removal prior to polymerization. The claimed further potential advantages of using restorative rein composite as a luting agent is their resistance to wear which proved to be superior to resin cements

Conditions

Cementation Teeth; Badly Broken Down Vital Teeth

Outcome Measures

Primary Outcomes (1)

• Clinical Performance

  Retention, marginal integrity, secondary caries, anatomic form, surface texture, proximal contact and postoperative hypersensitivity. All these outcomes are measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable ,charlie is not accepted

  18 months change from baseline to 6, 12, and 18 months

Study Arms (2)

Injectable restorative resin composite material used for cementation

EXPERIMENTAL

Highly filled injectable composites display properties in a manner similar to resin cements due to their unique viscosities. This with the added benefits of higher filler content, thus improved mechanical and physical properties with the easy placement and handling properties which can improve clinical performance and durability of indirect restorations. (Fugimoto et al., 2019)

Other: Injectable restorative resin composite

Dual cured resin cement

ACTIVE COMPARATOR

Dual cured resin cement is chosen as a comparator (gold standard )for the cementation of indirect restorations. (Sadighpour et al., 2018) Resin cement is insoluble and has superior mechanical and physical properties, compared with other previous luting materials. The clinical advantages of resin cement include high resistance to compression forces, low thermal expansion coefficients, high flexural strengths, and hardness. In addition, resin cement is characterized by adhesion to many materials, the ability to modify shade and color, high retention, resistance to wear at the margin of the restoration, and low marginal permeability. Resin cement provides optimal bond with resin composite indirect restorations and evenly distributes the compression force along all contact surfaces. (Gurdal et al., 2018

Other: Dual cured resin cement

Interventions

Injectable restorative resin composite OTHER

The introduction of injectable composites, according to available literature, offers a simple and efficient solution for the cementation of veneers. This versatile, injectable restorative composite unites easy handling, high physical properties and excellent aesthetics. Generally used as a restorative material, it can also be used for the cementation of veneers and some inlays/onlays, thus considered as good alternative to preheated composite. (Alajrash MM et al., 2020)

Injectable restorative resin composite material used for cementation

Dual cured resin cement OTHER

Resin cements are widely used due to their strong adhesion, and compatibility with various restorative materials, including ceramics and zirconia. They bond to enamel and dentin through functional monomers such as MDP, and 4-META, forming a stable hybrid layer. Based on their bonding mechanism, resin cements are classified as adhesive or self-adhesive, while their polymerization method -chemical, light, or dual-cure-allows for versatility in clinical applications

Dual cured resin cement

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with vital, asymptomatic, badly broken-down lower molar exhibiting at least two missing walls and one or more weakened or absent cusps (indicated for an onlay restoration), classified as ICDAS score (5)
• Patients with at least 20 teeth under occlusion.
• Age: 20-40 years.
• Males or females.
• Co-operative patients approving to participate in the trial.
• Good oral hygiene measures
• Teeth with no signs of pulpal involvement; healthy periodontal status; favorable occlusion
• Those in good general health.

You may not qualify if:

• Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis or periapical pathosis
• Teeth supporting removable prostheses, or orthodontic appliances.
• Candidates with parafunction or bruxism or temporomandibular joint disorders
• Candidates with systemic diseases or disabilities that may affect participation.
• Heavy smoking.
• Pregnancy.
• Lack of compliance.
• Severe or active periodontal disease
• Non-vital or endodontically treated teeth
• Xerostomia
• Drug addiction; or any condition that could compromise study compliance.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Ashraf H, El Tannir A, El Zohairy A, Kamal D. Clinical performance of indirect hybrid ceramic onlay restorations cemented with injectable resin composite versus dual-cure resin cement: an 18-month randomized clinical trial. BMC Oral Health. 2025 Sep 23;25(1):1419. doi: 10.1186/s12903-025-06903-5.

  PMID: 40988059 DERIVED

Study Design

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

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 20, 2023
• Study Start: August 1, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

EG (1)