Resin-Cement Type Influence on Cement Remnants in Implant-Supported Restorations

Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants

This study quantitatively compared cement residues of two resin cement types around implant-supported restorations (ISR) with a crown-abutment margin located at the gingival level. This prospective, single-blinded, cross-over clinical trial compared optically detectable cement remnants between Self-Adhesive Resin Cement (RC) and Resin-Modified Glass Ionomer Cement (RMGIC).

Study Overview

• Status: Completed
• Conditions: Dental Cements
• Intervention / Treatment: Other: self-adhesive resin cement (RC); Other: resin-modified glass-ionomer cement (RMGIC)

Detailed Description

This prospective, two-arm, non-randomized, clinical trial compared detectable cement remnants on 30 patients and 60 ISR. Two cements were compared; self-adhesive resin (RC) and resin-modified glass ionomer (RMGIC). Comparisons were carried out on identical pairs of ISR tested within the same patients with a 1-week healing interval. The primary outcome variable was the ratio of cement-covered area to total crown area. Areas were analyzed ex-situ by standardized digital image analysis.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 01362
    • Vilnius Implantology Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• physical and psychological ability to undergo implant therapy (ASA I or II)
• presence of a single mandibular molar indicated for extraction with adjacent healthy and present natural teeth or implant-supported restoration
• presence of ≥ 6 mm width and ≥ 10 mm height native bone ridge - presence of intact alveolar bone walls after tooth extraction and presence of interradicular bone > 4 mm to achieve primary implant stability
• presence of ≥ 1.5 mm distance to adjacent teeth at the bone level
• overall healthy, non-inflamed keratinized soft tissues.

Exclusion Criteria:

Presence of general conditions contributory to dental implant treatment comprising but not limited to:

• presence of active periodontitis 25
• poor oral hygiene as determined by the Oral Health Index (OHI)
• pregnant or lactating
• presence of uncontrolled medical systemic conditions, e.g. diabetes;
• ongoing or past medical treatments affecting wound healing, terminated less than 3 months prior to the study-related intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Adhesive Resin Cement (RC); Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.	Other: self-adhesive resin cement (RC); Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.; Other: resin-modified glass-ionomer cement (RMGIC); Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.
Experimental: Resin-modified Glass-Ionomer Cement (RMGIC); Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.	Other: self-adhesive resin cement (RC); Single-unit implant-supported single crowns were cemented to the abutments using a self-adhesive resin cement (RC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.; Other: resin-modified glass-ionomer cement (RMGIC); Single-unit implant-supported single crowns were cemented to the abutments using a resin-modified glass-ionomer cement (RMGIC). Residual cement was removed, and the restorations were retrieved for analysis of cement remnants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative ratio between the detectable area covered by cement remnants per crown site and the total crown	Digital photographs of the specimens were obtained using custom-made equipment with a standardized distance. The images were analyzed as follows: the contours of the area covered by residual cement were identified visually after optical magnification and marked; the contours comprising the entire surface area of the prosthetic superstructure, i.e. abutment and crown, were determined; the ratio between the area covered with cement and the total surface area per aspect of the specimen was calculated.	Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.

Collaborators and Investigators

• Sponsor: Vilniaus Implantologijos Centro (VIC) Klinika
• Collaborators: Harvard School of Dental Medicine
• Investigators: Principal Investigator: Eglė Vindašiūtė-Narbutė, Vilnius Implantology Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: peri-implant health; cemented restoration; implant-supported fixed dental prosthesis; cement remnants
• Other Study ID Numbers: VIC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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