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

NCT ID: NCT06711237

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Dental Cements

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

sequential design with a washout period
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

self-adhesive resin cement (RC)

Intervention Type 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)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

self-adhesive resin cement (RC)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard School of Dental Medicine

OTHER

Sponsor Role collaborator

Vilniaus Implantologijos Centro (VIC) Klinika

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eglė Vindašiūtė-Narbutė

Role: PRINCIPAL_INVESTIGATOR

Vilnius Implantology Center

Locations

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Vilnius Implantology Center

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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VIC1

Identifier Type: -

Identifier Source: org_study_id