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

Not Applicable

Completed

• Conditions: Dental Cements

• Registration Number: NCT06711237
• Lead Sponsor: Vilniaus Implantologijos Centro (VIC) Klinika

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).

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 Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vilnius Implantology Center; 🇱🇹 Vilnius, Lithuania