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

NCT06711237 | Completed

• 1 other identifier: VIC1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dental Cements

Keywords

cemented restoration; implant-supported fixed dental prosthesis; cement remnants; peri-implant health

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Self-Adhesive Resin Cement (RC)

EXPERIMENTAL

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); Other: resin-modified glass-ionomer cement (RMGIC)

Resin-modified Glass-Ionomer Cement (RMGIC)

EXPERIMENTAL

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); Other: resin-modified glass-ionomer cement (RMGIC)

Interventions

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); Self-Adhesive Resin Cement (RC)

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.

Resin-modified Glass-Ionomer Cement (RMGIC); Self-Adhesive Resin Cement (RC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vilniaus Implantologijos Centro (VIC) Klinika: lead
• Harvard School of Dental Medicine: collaborator

Study Sites (1)

Vilnius Implantology Center

Vilnius, 01362, Lithuania

Location

Study Officials

• Eglė Vindašiūtė-Narbutė

  Vilnius Implantology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: sequential design with a washout period

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 2, 2024
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)