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Completed

NCT Number: NCT06711237

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

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).

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vilnius Implantology Center

Vilnius, 01362, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-adhesive resin cement (RC)

Other

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.

resin-modified glass-ionomer cement (RMGIC)

Other

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.

Primary outcomes

  1. Relative ratio between the detectable area covered by cement remnants per crown site and the total crown

    Time frame: Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.

    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.

Sponsors and collaborators

Lead sponsor

Vilniaus Implantologijos Centro (VIC) Klinika

Network

Collaborators

  • Harvard School of Dental Medicine

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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