Clinical Evaluation of Ceramage Inlays Cemented With Beautilink Self-Adhesive Resin Cement Versus Rely X Resin Cement in Carious Posterior Teeth

Eighteen Months Clinical Evaluation of Hybrid Ceramic Inlays Cemented With Giomer Based Self-adhesive Resin Cement Versus Resin-based Cement in Carious Posterior Teeth: Randomized Controlled Clinical Trial

Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.

The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.

Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.

Study Overview

• Status: Active, not recruiting
• Conditions: Caries Class Ii
• Intervention / Treatment: Other: Beautilink SA cement; Other: RelyX resin cement

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 002
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Posterior vital tooth with a large carious lesion (ICDAS 4/5)
• Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
• Vital, periodontally sound and with positive reaction to cold stimulus.
• Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.

Exclusion Criteria:

• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth, Fractured or cracked teeth.
• Endodontically treated teeth.
• Periodontally affected teeth.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cementation via Beautilink SA cement; Ceramage inlays will be cemented using Beautilink SA cement; To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.; Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.; Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing.	Other: Beautilink SA cement; According to the manufacturer's instructions (BeautiLink SA - Shofu USA); To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.; Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.; Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material.; Light-cure the excess material for 1-2 sec with a light-curing unit followed by removal of the tack-cured material with a probe.; Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing.
Active Comparator: Cementation via RelyX resin cement; Ceramage inlays will be cemented using RelyX resin cement; To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.; Application of 3M™RelyX™ Universal Resin Cement into the cavity; Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing.	Other: RelyX resin cement; According to the manufacturer's instructions (Espe).; To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.; Application of 3M™RelyX™ Universal Resin Cement into the cavity; Seat the restoration in the cavity and apply proper pressure after using Teflon to protect the adjacent teeth and help in the removal of the excess material.; Light-cure the excess material for 2-3 sec with a light-curing unit followed by removal of the tack-cured material with a probe.; Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria	Alpha being the best results and Charlie being the worst results	T0: 12 months T1: 18 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Inlays; Ceramage
• Other Study ID Numbers: 20091993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No